[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endometrial-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endometrial-cancer":820},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,255,0,25,[9,46,70,110,137,173,207,237,269,305,342,402,431,454,521,537,565,582,616,639,664,697,725,772,798],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100054312",false,"NCT07270666","ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer","Pragmatic Pilot Study of ctDNA Informed Immune Checkpoint Inhibitor De-escalation in Advanced\u002FRecurrent Mismatch Repair Deficient (MMR-D)\u002FMicrosatellite Instability High (MSI-H) Endometrial Cancer Using Standard of Care Treatments","Inclusion Criteria:\n\n* Patients must have pathologically confirmed endometrial cancer\n* Patients with advanced endometrial cancer\n* Stage III with residual disease\n\n  °Select patients with Stage III disease and no residual disease can be enrolled after discussion with PI\n* Stage IV\n* Recurrent endometrial cancer after adjuvant therapy only\n* Patients can have primary or planned interval surgery\n* MMR-D on immunohistochemistry OR MSI-H using any commercially available test\n* Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression.\n* Eligible for standard of care chemotherapy with immune checkpoint inhibitor per treating investigator with no clinical contraindications\n* For the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments, they need to be on treatment with no clinical evidence of disease progression.\n\n  * Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fpara aortic radiation therapy, intravaginal brachytherapy, and\u002For palliative radiation therapy.\n  * Patients may have received prior hormonal therapy for treatment of endometrial cancer.\n  * Patients may not have received prior therapy with an anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.\n\n    * Except for the up to 10 patients who are allowed to enroll after C1D1 of standard of care treatments (chemotherapy and\u002For immune checkpoint inhibitors) per protocol.\n* Age ≥ 18\n* Not Pregnant and Not Nursing","FEMALE","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","The researchers are doing this study to evaluate the use of circulating tumor DNA (ctDNA) testing in making treatment decisions for advanced\u002Frecurrent endometrial cancer that has a change (mutation) in the mismatch repair deficient (MMR-D) gene or microsatellite instability high (MSI-H) gene. The researchers will see how doctors and their patients use the results of ctDNA testing after 1 year of standard chemotherapy and immune checkpoint inhibitor (ICI) treatment to decide whether to continue maintenance ICI treatment past 1 year. The researchers will also look at the health outcomes of people in this study (for example, whether they are cancer free at the end of their participation in the study).",[26],"Endometrial Cancer",[28,29,30,31,32],"Stage III with residual disease","Stage IV","Recurrent endometrial cancer after adjuvant therapy only","ctDNA Testing","25-337","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2025-11-25",{"date":41,"type":20},"2027-11",{"name":43,"class":44},"Memorial Sloan Kettering Cancer Center","OTHER",7,{"id":47,"slug":4,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100053701","NCT07139977","Study of EV for Recurrent Endometrial Carcinoma","Open-Label Phase II Trial of Enfortumab Vedotin in Recurrent or Persistent Endometrial Carcinoma","EV-4-EC","Inclusion Criteria:\n\n1. Female patient of age ≥18 years.\n2. Recurrent and progressive endometrial cancer, all stages at primary diagnosis. The histology types will be pending the preclinical assessments, but can include:\n\n   1. Endometrioid endometrial carcinoma\n   2. Serous endometrial carcinoma\n3. Prior standard of care of surgical intervention, including hysterectomy.\n4. Evidence of disease progression on or following the most recent line of therapy prior to screening. Therapy must include platinum-based chemotherapy. If the patient is eligible for immunotherapy, this must have been provided. Patient may have received either radiation therapy or hormone therapy, neither of which will be considered a line of therapy. Chemotherapy during radiotherapy will not be considered a line of therapy.\n5. Maximum of three prior lines of therapy. Neo-adjuvant and postsurgical therapy, if provided, will be counted as 1 line of therapy. Therapy given in a maintenance fashion after primary treatment will not be counted as a line of therapy.\n6. IHC expression of nectin-4.\n7. Toxicity from prior treatment recovered to G1 or G0.\n8. ECOG status of 1 or 0.\n9. At least 1 measurable target lesion according to RECIST v1.1, including the following criteria:\n\n   1. Non-nodal lesion that measures ≥ 1.0 cm in the longest diameter.\n   2. Lymph node (LN) lesion that measures as ≥ 1.5 cm in the short axis.\n   3. The lesion is suitable for repeat measurement using computed tomography\u002Fmagnetic resonance imaging (CT\u002FMRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of subsequent growth after treatment.\n10. Documented tumor status for MSI and MMR.\n11. In the opinion of the investigator, the patient must have a life expectancy of at least 12 weeks and be well enough to receive experimental therapy.\n12. Adequate organ function as determined by laboratory tests defined in the table below at screening.\n\n    Hematological: Absolutely neutrophil count (ANC)≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Hemoglobin ≥ 9.0 g\u002FdL or 5.6 mmol\u002FL, No erythropoietin dependency or packed red blood cell transfusion within last 2 weeks.\n\n    Renal: Creatinine, OR ≤ 1.5 x ULN, Creatinine clearance as calculated per institutional standard ≥ 30 mL\u002Fmin for patients with creatinine \\> 1.5 × institutional ULN Hepatic: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) ≤ 3 ULN for participants with Gilbert's syndrome. AST, ALT ≤ 3 × ULN (≤ 5 × ULN for participants with liver metastases\n13. Ability to understand a written informed consent document, and the willingness to sign it.\n14. Pregnancy: It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Nonsterilized female patients of reproductive age and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below. Female patients must meet one of the following:\n\n    1. Postmenopausal for at least one year before the screening visit, or\n    2. Surgically sterile, or\n    3. If they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through three months after the last dose of study drug, AND\n    4. Must also adhere to the guidelines of any treatment specific pregnancy prevention program, if applicable, or\n    5. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable contraception methods.) Male patients\u002Fpartners of patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:\n\n    \u003C!-- -->\n\n    1. Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR\n    2. Must also adhere to the guidelines of any treatment specific pregnancy prevention program, if applicable, OR\n    3. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n\nExclusion Criteria:\n\n1. Diagnosis of endometrial sarcoma (leiomyosarcoma, endometrial stromal sarcoma, high-grade sarcoma).\n2. Diagnosis of non-endometrioid and non-serous endometrial cancer. Mixed tumors involving histologic types other than serous and endometrioid will not be eligible.\n3. Tumor sample does not express nectin-4 (local IHC testing).\n4. Symptomatic CNS metastases or leptomeningeal metastases. Patients with symptomatic brain metastasis must be treated and must be stable for at least 4 weeks prior to study treatment.\n5. Active second malignancy with anti-cancer treatments (except for treated in-situ carcinomas \\[e.g., breast, cervix, bladder\\], or basal or squamous cell carcinoma of the skin) within the past 24 months.\n6. Sensory or motor neuropathy ≥ G2\n7. Prior history of significant cardiovascular impairment within 12 months of the first dose of study drug: such as history of congestive heart failure greater than New York Heart Association (NYHA)Class II, unstable angina, myocardial infarction, or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability.\n8. Active infection requiring systemic IV antibiotics within 14 days, or oral antibiotics within 7 days, prior to administration of study drugs. Regular treatment of urinary tract infection (UTI) and\u002For topical treatment are allowed.\n9. Uncontrolled diabetes defined as HgbA1c of ≥ 8%.\n10. Hepatitis B, C, or HIV infection.\n11. Have not recovered to CTCAE v5.0 Grade 0 or 1 (except chemotherapy related grade 2 peripheral neuropathy, or grade 2 endocrinopathy with adequate replacement therapy) from any toxicity and\u002For complications from major surgery or prior cancer therapeutics before starting therapy.\n12. Ongoing treatment for EC, including radiation therapy, hormonal therapy, chemotherapy, immunotherapy, or any investigational therapy, unless they have been discontinued at least 4 weeks prior to screening and there is no plan to re-initiate during the study. radiation therapy is allowed prior to and during study drug administration as long as there are no acute toxicities.\n13. Active intestinal obstruction.\n14. Known psychiatric or substance use disorders that would interfere with cooperation with the requirements of the trial.\n15. Any conditions that required systemic immunosuppression therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) within 7 days prior to the first dose of study drug.\n16. Pregnant or lactating patients.\n17. In the opinion of the Investigator, have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or make study participation, not in the best interest of the patient. The Investigator should discuss with the Sponsor and\u002For study leaders.",{"count":54,"type":20},12,[56],"PHASE2","This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous treatments, including immunotherapy. The goal is to see how well the drug works and how safe it is. Patients will be treated for up to one year and followed over time to monitor their health and response to the treatment.",[26],[60,61,62],"endometrial cancer","endometrioid","serous endometrial carcinoma",{"date":36,"type":37},{"date":34,"type":20},{"date":66,"type":20},"2028-05-31",{"name":68,"class":44},"William Bradley",1,{"id":71,"slug":4,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100597545","NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-","ALL",{"count":78,"type":20},104,[23],"This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[82,83,84,85,86,87,26,88,89,90,91,92,93,94,95,96,97,98,99],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Head and Neck Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Sarcoma","2026-07-01",{"date":102,"type":37},"2026-07-02",{"date":104,"type":37},"2026-02-11",{"date":106,"type":20},"2027-08-31",{"name":108,"class":44},"Alliance for Clinical Trials in Oncology",18,{"id":111,"slug":4,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":136},"100633256","NCT07524322","Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors","A Phase 1\u002F1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+\u002FHER2- Breast Cancers","Inclusion Criteria:\n\n* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.\n* Presence of one or more documented activating PIK3CA mutation in tumor tissue and\u002For blood.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diabetes mellitus requiring anti-hyperglycemic medication.\n* Prior treatment with PI3Kα inhibitors\n* Symptomatic, untreated, or uncontrolled central nervous system metastases.\n* Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.\n* Unresolved clinically significant toxicities from prior anticancer therapy\n* History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).",{"count":117,"type":20},63,[119],"PHASE1","This is a phase 1\u002F1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.\n\nParticipants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.",[85,95,26,122,123,124,125,126,86],"PIK3CA Mutation","HER2- Negative Breast Cancer","Advanced Breast Cancer","Unresectable Solid Tumor","Hormone Receptor Positive Tumor","2026-06-30",{"date":102,"type":37},{"date":130,"type":20},"2026-06",{"date":132,"type":20},"2028-10",{"name":134,"class":135},"Regor Pharmaceuticals Inc.","INDUSTRY",5,{"id":138,"slug":4,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":152,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100622429","NCT07383506","A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors","A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations","Inclusion Criteria:\n\n1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and\u002For tumor:\n\n   1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer\n   2. Phase 1b Cohort 2, participants must have HR-positive\u002FHER2-negative or HER2-low breast cancer (immunohistochemistry \\[IHC\\] and in-situ hybridization results must meet ASCO-College of American Pathology guidelines for breast cancer or criteria)\n   3. Phase 1b Cohort 3 will allow all solid tumors that do not meet criteria for Phase 1b Cohorts 1 or 2, including head and neck cancers, other gynecological cancers, colorectal cancers harboring PIK3CA mutations\n2. Meet prior treatment requirement of:\n\n   1. Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n   2. Phase 1b: previously treated with or considered not appropriate for SOC first-line treatment for their condition\n3. Have at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1\n5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits\n6. Resolution of acute toxicities from prior anticancer therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities (other than parameters specified in screening testing as outlined below), as determined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) v5.0.\n7. Have an ejection fraction ≥50%\n\nExclusion Criteria:\n\n1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.\n2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug\n3. Treatment with radiotherapy ≤2 weeks before the first dose of study drug.\n4. Clinically significant cardiac disease\n5. Ongoing or planned long-term (≥4 consecutive weeks) treatment with glucocorticoid steroids at greater than physiologic dosing (defined as equivalent to \\>20 mg\u002Fday prednisone)\n6. Diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 (defined as fasting glucose ≥140 mg\u002FdL and HbA1c ≥7.0%; antihyperglycemic medical management permitted with the exception of insulin)\n7. Previous molecular testing (NGS or PCR) showed tumor with the following mutations: mutations\u002Fdeletions in PTEN or activating mutations in AKT, HRAS\u002FKRAS\u002FNRAS, EGFR, and BRAF",{"count":144,"type":20},90,[119],"This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations",[148,149,26,150,151],"PIK3CA Mutations","Advanced Solid Tumors, Adult","HR Positive\u002FHER-2 Negative Breast Cancer","HER2-low Breast Cancer",[153,154,155,156,148,157,26,85,158,159,160,161,162,163,164,151,165],"HER2","PI3K","Mutant-Selective Inhibitor","Advanced solid tumors","PIK3CA SNVs","HR+\u002FHER2 Negative breast cancer","HR+\u002FHER2 (-) breast cancer","HR+\u002FHER2 low breast cancer","PI3KCA Genetic Alterations","PI3KCA Point Mutations","PI3KCA Gene Short Variants","PI3KCA active alteration","Phase 1a\u002F1b",{"date":100,"type":37},{"date":130,"type":20},{"date":169,"type":20},"2029-08",{"name":171,"class":135},"Cogent Biosciences, Inc.",4,{"id":174,"slug":4,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":189,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":109},"100532907","NCT06218914","Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and\u002For Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with NSCLC, Colorectal adenocarcinoma, Pancreatic adenocarcinoma, Endometrial Cancer or any other solid tumor\n* Tumors must harbor a KRAS G12D variant mutation and subject must be HLA-C\\*08:02 positive, HLA-A\\*11:01 or HLA-A\\*11:02 positive in at least one allele\n* Subject has advanced solid cancer, defined as unresectable, advanced, and\u002For metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options.\n* Presence of at least 1 measurable lesion per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment\n\nKey Exclusion Criteria:\n\n* Any other primary malignancy within the 3 years prior to enrollment (except for non-melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or low-grade prostate cancer\n* Known, active primary central nervous system (CNS) malignancy\n* History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation.\n* History of stroke or transient ischemic attack within the 12 months prior to enrollment.\n* History of clinically significant cardiac disease within the 6 months prior to enrollment or heart failure at any time prior to enrollment.\n* Systemic therapy within at least 2 weeks or 3 half-lives, whichever is shorter, prior to enrollment.\n* Any form of primary immunodeficiency.\n* Active immune-mediated disease requiring systemic steroids or other immunosuppressive treatment (except if related to prior checkpoint inhibitor therapy)\n* Female of childbearing potential who is lactating or breast feeding at the time of enrollment\n* Prior treatment with pan-KRAS or KRAS G12D targeting agents unless presence of KRAS G12D mutation is confirmed after the completion of treatment with pan-KRAS or KRAS G12D targeting agents.",{"count":180,"type":20},108,[119],"Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and\u002For Metastatic Solid Tumors.",[184,185,186,26,187,188],"Non-small Cell Lung Cancer","Colorectal Carcinoma","Pancreatic Ductal Adenocarcinoma","Solid Tumor, Adult","KRAS G12D",[190,191,188,192,193,194,195,196,186,197,198,199],"TCR-T cell therapy","KRAS","Autologous","PDAC","NSCLC","Colorectal Cancer","Solid tumors","HLA-C*08:02","HLA-A*11:01","HLA-A*11:02",{"date":100,"type":37},{"date":202,"type":37},"2024-03-22",{"date":204,"type":20},"2043-11-18",{"name":206,"class":135},"AstraZeneca",{"id":208,"slug":4,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":21,"phases":215,"briefSummary":216,"conditions":217,"keywords":224,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100575356","NCT06771219","SLV-154 Treatment of Metastatic Solid Tumors","A Phase 1 Dose-Escalation Study of SLV-154 in Subjects With Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Men or women (as appropriate for cancer type) of age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n3. Histologically or cytologically confirmed diagnosis of solid tumor as documented in medical records with the primary history comprising one of the following:\n\n   1. SCCHN\n   2. NSCLC\n   3. SCLC\n   4. Breast cancer\n   5. Cervical cancer\n   6. Endometrial cancer\n   7. Ovarian cancer\n   8. Urothelial cancer\n   9. Sarcoma\n   10. Thyroid cancer\n4. Presence of metastatic disease that has progressed during or following previous treatment.\n5. Presence of radiographically measurable disease.\n6. Prior receipt of commercially available therapies that are indicated for the subject's cancer and have demonstrated survival benefit for that indication.\n7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.\n8. Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and\u002For fluorodeoxyglucose (FDG) positron emission tomography (PET)\u002FCT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.\n9. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.\n10. Adequate hematological profile.\n11. Adequate coagulation profile.\n12. Adequate hepatic profile.\n13. Adequate renal function.\n14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.\n15. For female subjects of childbearing potential, a negative serum pregnancy test.\n16. For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.\n17. For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.\n18. Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy\u002Faspirations and\u002For radiographic studies), and study restrictions.\n19. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\n1. Malignancy involving the central nervous system unless brain metastases have been previously treated with radiotherapy, have been stable for ≥4 weeks, and do not require corticosteroids.\n2. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.\n3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.\n4. Significant cardiovascular event or comorbidity.\n5. Significant screening ECG abnormalities.\n6. Pregnancy or breastfeeding.\n7. Major surgery within 4 weeks before the start of study therapy.\n8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.\n9. Use of a drug known to prolong the QT interval within 7 days prior to the start of study drug administration.\n10. Concurrent participation in another therapeutic or imaging clinical trial.\n11. Other conditions likely to interfere with a subject's ability to participate in the study.",{"count":214,"type":20},70,[119],"This is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.",[218,194,219,220,221,26,95,222,99,223],"Squamous Cell Cancer of Head and Neck (SCCHN)","SCLC","Cervical Cancer Metastatic","Breast Cancer Metastatic","Urothelial Cancer","Thyroid Cancer",[225,226,227],"metastatic solid tumors","metastatic cancer","solid tumor","2026-06-29",{"date":127,"type":37},{"date":231,"type":37},"2025-05-14",{"date":233,"type":20},"2027-04",{"name":235,"class":135},"Solve Therapeutics",10,{"id":238,"slug":4,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":21,"phases":246,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":268},"100542261","NCT06340568","A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer","A Phase III, Randomized, Multi-site, Open-label Trial of BNT323\u002FDB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer","Fern-EC-01","Key Inclusion Criteria:\n\n* Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent).\n* Have histologically confirmed endometrial cancer that:\n\n  * Is recurrent,\n  * Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2 expression, and\n  * Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed.\n* Have measurable disease defined by RECIST v1.1.\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Have recurrent endometrial cancer and meet any of the following:\n\n  * developed recurrence \\\u003C12 months from completing platinum-based chemotherapy given as adjuvant therapy for Stage I to III disease, or\n  * developed recurrence after platinum-based chemotherapy in the recurrent\u002Fmetastatic setting.\n* Have received prior ICI treatment (i.e., anti-programmed death 1\u002Fanti-programmed death-ligand 1)\n* Have a life expectancy of ≥12 weeks at screening.\n\nKey Exclusion Criteria:\n\n* Are ineligible for all options in the investigator's choice of chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only).\n* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of study treatment.\n* Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks prior to the first dose of study treatment.\n* Have a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Participants with prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg\u002Fday of prednisone or equivalent, and topical corticosteroids. Participants receiving corticosteroids may continue if the dose is stable upon giving main informed consent.\n* Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to the first dose of study treatment, severe asthma, chronic obstructive pulmonary disorder with moderate acute exacerbations, restrictive lung disease, pulmonary fibrosis, radiation pneumonitis, significant pleural effusion etc.), or any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and\u002For prior pneumonectomy (complete).\n* Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of study treatment.\n* Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia, fatigue, or endocrinopathies that are well controlled) not yet resolved to Grade ≤1 or baseline.\n* Are pregnant or breastfeeding or are planning pregnancy during the study or within 7 months after the last dose of study treatment.\n* Have a history of allergies, hypersensitivities, or intolerance to study treatments (investigational medicinal products and auxiliary medicinal product) including any excipients thereof or to other monoclonal antibodies. Participants who have successfully undergone a desensitization process and are able to tolerate the drug are eligible.\n* Had prior treatment with topoisomerase I inhibitors, including ADCs.\n* Have left ventricular ejection fraction \\\u003C55% by either echocardiography or multiple-gated acquisition within 28 days prior to the first dose of study treatment. This includes participants with tissue doppler E\u002Fe' ratio \\>15.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.",{"count":245,"type":20},480,[247],"PHASE3","The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.\n\nIn Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel \\[or docetaxel, if participants cannot take paclitaxel\\]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs).\n\nIn Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment.\n\nThe safety of BNT323 will also be assessed by following the occurrence of unfavorable\u002Fadverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.",[26],[251,252,253,254,255,256,257,258,259,260],"Human epidermal growth factor receptor 2 (HER2)","HER2-expressing tumors","Recurrent endometrial cancer","IHC scores 1+, 2+, and 3+","Immune checkpoint inhibitor","Platinum-based therapy","HER2 protein expression","HER2-expressing endometrial cancer","ErbB-2 receptor","Antibody drug conjugate (ADC)",{"date":127,"type":37},{"date":263,"type":37},"2025-06-10",{"date":265,"type":20},"2029-11",{"name":267,"class":135},"BioNTech SE",163,{"id":270,"slug":4,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":279,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":278,"type":20},100,"OBSERVATIONAL","This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[282,83,283,86,26,88,89,284,94,92,285,286,287,288,95,96,97,289,290,99,291,292,293,223,294,295,296],"Adenocarcinoma (NOS)","Bladder Cancer","Gastrointestinal Stromal Tumour","Melanoma","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Renal Cell Carcinoma","Salivary Gland Cancer","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Urethral Cancer","Vaginal Cancer","Vulvar Cancer","2026-06-26",{"date":228,"type":37},{"date":300,"type":37},"2025-09-18",{"date":302,"type":20},"2028-03-30",{"name":206,"class":135},17,{"id":306,"slug":4,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":279,"phases":4,"briefSummary":314,"conditions":315,"keywords":325,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":341},"100618120","NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).",{"count":313,"type":20},2000,"This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[316,317,318,283,319,195,320,321,26,94,91,92,322,323,324],"Cancer","Immunotherapy","Advanced Solid Tumors Cancer","TNBC, Triple Negative Breast Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer","Melanoma (Skin Cancer)",[317,326,327,316,328,329,330,331,332,333],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","2026-06-25",{"date":228,"type":37},{"date":337,"type":37},"2025-04-14",{"date":339,"type":20},"2038-04",{"name":327,"class":135},8,{"id":343,"slug":4,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":348,"sex":76,"minAge":349,"maxAge":350,"enrollmentInfo":351,"targetDuration":353,"studyType":279,"phases":4,"briefSummary":354,"conditions":355,"keywords":384,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100210159","NCT02012699","Integrated Cancer Repository for Cancer Research","iCaRe2","Inclusion Criteria\n\n* Diagnosis\u002Fhistory of cancer\n* Risk for developing cancer or suspicious clinical findings\n* No history of cancer (normal control registry)\n* Able to provide informed consent\n* 19 years of age or older\n* English or Spanish speaking individuals\n\nExclusion Criteria\n\n* Unable to provide informed consent because of cognitive impairment\n* Non-English or non-Spanish speaking individuals",true,"19 Years","110 Years",{"count":352,"type":20},999999,"80 Years","The iCaRe2 is a multi-institutional resource created and maintained by the Fred \\& Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.",[96,223,93,88,356,87,98,357,83,358,359,360,90,92,361,362,363,364,283,91,365,97,292,366,294,367,368,369,370,371,372,373,374,290,323,375,376,377,85,378,285,99,379,380,95,26,295,381,382,383],"Thymus Cancer","Gastrointestinal Stromal Tumors","Bile Duct Cancer","Duodenal Cancer","Gallbladder Cancer","Small Intestine Cancer","Peritoneal Surface Malignancies","Familial Adenomatous Polyposis","Lynch Syndrome","Penile Cancer","Ureter Cancer","Hypopharyngeal Cancer","Laryngeal Cancer","Lip Cancer","Oral Cavity Cancer","Nasopharyngeal Cancer","Oropharyngeal Cancer","Paranasal Sinus Cancer","Nasal Cavity Cancer","Central Nervous System Tumor","Central Nervous System Cancer","Mesothelioma","Leukemia","Unknown Primary Tumor","Multiple Myeloma","Neuroendocrine Tumors","Plasma Cell Dyscrasia","Healthy Control",[96,223,385,386,387,388,389,390,391,392,85,393,382,383],"Esophageal cancer","Thymus cancer","Pancreatic tumor","Esophageal tumor","Thymus tumor","Thyroid Tumor","Thyroid Nodule","Lung Tumor","Neuroendocrine tumor",{"date":228,"type":37},{"date":396,"type":37},"2013-11-01",{"date":398,"type":20},"2099-12",{"name":400,"class":44},"University of Nebraska",42,{"id":403,"slug":4,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":412,"conditions":413,"keywords":418,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":45},"100492351","NCT05691010","A Study of Short-Course Radiation Therapy With Chemotherapy in People With Endometrial Cancer","A Feasibility Study of Integrated Delivery of Hypofractionated Pelvic IMRT With Carboplatin and Paclitaxel in Stage III Copy-Number Low and Copy-Number High Subtypes of Endometrial Cancer","Inclusion Criteria:\n\n* Patients must have newly diagnosed endometrial carcinoma. The following histologic subtypes are eligible for inclusion: endometrioid, serous, clear cell, dedifferentiated\u002Fundifferentiated, mixed epithelial, adenocarcinoma not otherwise specified, and carcinosarcoma.\n* Surgery must have included a hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymph node surgical assessment (sentinel lymph node mapping and\u002For sampling). Para-aortic lymph node surgical assessment is optional.\n* Patients must have FIGO (2009) stage IIIA or IIIC1 disease (as determined by surgical staging).\n* Patients must consent to testing with MSK-IMPACT part A and are encouraged to consent to both parts A and C.\n* Age ≥ 18 years.\n* Patients must have an Karnofsky Performance Status (KPS) ≥ 70 (or ECOG 0 or 1).\n* Neurologic function: Neuropathy (sensory and motor) grade ≤ 1.\n* No residual gross disease after surgery.\n* No prior radiation therapy or chemotherapy for treatment of endometrial cancer.\n* No active infection requiring antibiotics, except for uncomplicated urinary tract infection.\n* Patients must have adequate organ function, defined by the following laboratory results prior to first study treatment:\n\n  * Absolute neutrophil count (ANC) ≥ 1500\u002FmcL\n  * Platelet count ≥ 100,000\u002FmcL\n  * AST\u002FALT ≤ 3X upper limit of normal (ULN)\n  * Total bilirubin ≤ 1.5X ULN. Patients with known Gilbert's disease and a total bilirubin ≤ 3X ULN may be enrolled.\n  * Creatinine ≤ 1.5X ULN\n* Entry into study is limited to no more than 12 weeks from the date of surgery.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients of childbearing age will by definition have undergone hysterectomy and bilateral oophorectomy prior to study enrollment.\n* Participants must agree not to breastfeed during the study or for 150 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Patients whose endometrial cancers harbor known pathogenic POLE mutations\n* Patients whose endometrial cancers are mismatch repair deficient, as determined by immunohistochemical staining for MLH1, PMS2, MSH2, and MSH6 and\u002For MSI-H\n* Active inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. This includes but is not limited to: uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, and superior vena cava syndrome.\n* Patients unfit for pelvic radiation therapy due to the following:\n\n  * Has had radiation therapy encompassing \\>20% of the bone marrow within 2 weeks, or any radiation therapy within 1 week prior to day 1 of protocol therapy\n  * Patients with a history of pelvic radiation.\n  * Patients with a history or current diagnosis of a vesicovaginal, enterovaginal, or colovaginal fistula.\n  * Any hematological abnormality or disorder that would be a contraindication to radiation per the treating physician.",{"count":409,"type":20},28,[411],"EARLY_PHASE1","The purpose of this study is to find out whether short-course radiation therapy (1 week instead of the usual 5 weeks) with chemotherapy (carboplatin and paclitaxel) is practical (feasible), meaning that most participants are able to complete the treatment schedule.",[26,414,415,416,417],"Stage III Endometrial Cancer","Stage III Endometrial Carcinoma","Endometrial Carcinoma","Endometrial Carcinoma Stage III",[60,419,420,421,422,43,423],"endometrial cancer stage III","endometrial carcinoma stage III","stage III endometrial cancer","stage III endometrial carcinoma","22-405","2026-06-24",{"date":334,"type":37},{"date":427,"type":37},"2023-01-10",{"date":429,"type":20},"2027-01-10",{"name":43,"class":44},{"id":432,"slug":4,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":21,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":453},"100468301","NCT05377996","A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","A Phase 1\u002F2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors","Inclusion Criteria:\n\n* Recurrent or advanced solid tumor and has disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Participants in DES must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.\n* Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1\n* Brain magnetic resonance imaging (MRI) during the Screening period unless obtained within 30 days prior to Screening (based on standard clinical care), if they meet either of the following criteria:\n\n  1. All participants with TNBC\n  2. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.\n\nExclusion Criteria:\n\n* Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.\n* Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.\n* Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.\n* Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.\n* Prior B7-H4 targeted treatment.\n* History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.\n* Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.\n* Clinically significant cardiovascular disease\n* Active keratitis (inflammation of the cornea of the eye)",{"count":438,"type":20},360,[119,56],"A Study of Emi-Le in Participants with Solid Tumors",[442,85,26,95,443,444,445],"Triple Negative Breast Cancer","Fallopian Tube Cancer","Primary Peritoneal Cavity Cancer","Adenoid Cystic Carcinoma",{"date":228,"type":37},{"date":448,"type":37},"2022-08-15",{"date":450,"type":20},"2027-12",{"name":452,"class":135},"Day One Biopharmaceuticals, Inc.",26,{"id":455,"slug":4,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":76,"minAge":460,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":21,"phases":463,"briefSummary":464,"conditions":465,"keywords":484,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":520},"100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":462,"type":20},300,[119,56],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[466,467,468,469,93,95,26,97,195,85,470,471,94,89,291,472,473,194,474,219,475,442,476,477,478,479,480,481,482,483],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Other Cancer","Locally Advanced","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC (Non-small Cell Lung Cancer)","Non-Small Cell Lung Carcinoma","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505,506,507,508,509,510,511,512],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":297,"type":37},{"date":515,"type":37},"2020-10-29",{"date":517,"type":20},"2027-12-31",{"name":519,"class":135},"PMV Pharmaceuticals, Inc",77,{"id":522,"slug":4,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":11,"sex":76,"minAge":4,"maxAge":4,"enrollmentInfo":526,"targetDuration":4,"studyType":279,"phases":4,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":69},"100592623","NCT06995833","Durvalumab With or Without Olaparib in Patients With Endometrial Cancers Regulatory Post Marketing Surveillance","Inclusion Criteria:\n\n1. Patients eligible for the study drug according to the approved label in Korea\n2. Provision of a signed and dated written informed consent by the patient or their legally acceptable representative\n\nExclusion Criteria:\n\n1. Participation in any concurrent interventional trials during the period of the study drug treatment\n2. Other off-label indications according to the approved label in Korea",{"count":527,"type":20},50,"Objectives of this study are to assess the safety and effectiveness of Durvalumab with or without Olaparib (hereinafter \"the study drug\") in a real world setting in patients who are prescribed with the study drug under the approved indication in Korea.\n\nThis is a multicenter, prospective, observational, real world treatment study. Patients treated as part of routine practice at Korean healthcare centers by investigators will be identified and considered for inclusion in the study. The period of this study is expected to run for 4 years from the approval date of the indication for this study. Approximately 50 patients are expected to be enrolled during the study.\n\nPatient will be followed for approximately 12 months from the first dose or up to 90 days after treatment discontinuation if the study drug is administered for less than 12 months, unless they withdraw consent, are lost to follow-up or death.",[26],"2026-06-23",{"date":424,"type":37},{"date":533,"type":37},"2025-09-19",{"date":535,"type":20},"2029-06-29",{"name":206,"class":135},{"id":538,"slug":4,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":276,"enrollmentInfo":544,"targetDuration":4,"studyType":279,"phases":4,"briefSummary":546,"conditions":547,"keywords":548,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":564},"100584510","NCT06890273","NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)","Prospective NIS to Generate Real-World-Data on Effectiveness and Safety of First-line Therapy With Chemotherapy Combined With Durvalumab Followed by Maintenance Therapy With Durvalumab or Durvalumab + Olaparib in Endometrial Cancer","DUOLife","Inclusion Criteria:\n\n* Women aged ≥ 18 years at the time of screening.\n* Patient has pathologically documented:\n* Primary advanced (FIGO III and IV) epithelial EC OR\n* Recurrent disease that is unlikely to be cured and where the multidisciplinary tumor board decision is systemic therapy. Carcinosarcomas are allowed,\n* Patient is intended or initiated to receive 1L CPD followed by maintenance therapy with durvalumab (dMMR cohort) or with durvalumab and olaparib (pMMR cohort) according to the SmPC of IMFINZI® and Lynparza®\\* prior to enrollment. Recruitment of patients that already started and may have received up to 2 cycles of CPD is allowed but will be capped to 25% for each cohort of the study population.\n* Patient is eligible for treatment with durvalumab and\u002For olaparib as specified in the IMFINZI® and Lynparza® SmPC. The prescription of the medicinal product is clearly separated from the decision to include the patient in the study.\n* MMR-testing results of the patient's tumor are known.\n* Patient is willing and able to complete PRO questionnaires.\n* Patient can read and understand German, English, Arab, Russian or Turkish.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patient has already received \\>2 cycles of 1L CPD\n* Known hypersensitivity to carboplatin, paclitaxel, durvalumab and\u002For olaparib or any of the excipients of the drug.\n* Pregnancy or breast-feeding.\n* Unable to swallow orally administered medication.\n* Current or planned participation in an interventional clinical trial.\n* Current or planned systemic treatment of any tumor other than primary advanced or recurrent EC.\n* Patient has pathologically documented sarcoma",{"count":545,"type":20},150,"This is a German multi-center, prospective, non-interventional study (NIS) to collect real-world clinical data in patients with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer (EC) receiving first-line (1L) regimens with Carboplatin\u002FPaclitaxel\u002FDurvalumab (CPD) followed by maintenance therapy with durvalumab or durvalumab and olaparib in line with the applicable european summary of product characteristics (SmPC). Additionally, patient-reported outcomes after 1L treatment with CPD will be assessed.",[26],[549,550,551,552,553,554,555,556,557],"Durvalumab","Olaparib","Primary advanced endometrial cancer (1L)","FIGO III or IV","Recurrent endometrial cancer (1L)","dMMR","pMMR","Real-World Evidence","Patient-Reported Outcome",{"date":424,"type":37},{"date":560,"type":37},"2025-05-20",{"date":562,"type":20},"2029-03-31",{"name":206,"class":135},49,{"id":566,"slug":4,"hasResults":11,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":571,"enrollmentInfo":572,"targetDuration":4,"studyType":21,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":580,"locationsCount":69},"100349634","NCT03832361","Evaluation of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Endometrial Cancer","A Phase II Evaluation of the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) in Women With Folate Receptor-α Positive Persistent or Recurrent Endometrial Cancer","Inclusion Criteria:\n\n* Radiologically confirmed (ie, CT scan and\u002For MRI) persistent or recurrent endometrial cancer\n* Patients must have one of the following pathologically documented, definitively diagnosed tumor types: Uterine serous carcinoma (Pure or Mixed), Grade 2 or Grade 3 endometrial adenocarcinoma, Carcinosarcoma with high grade serous or Grade 2\u002F3 endometrioid components, or clear cell carcinoma (Pure or Mixed).\n* Have measurable disease\n* FRα-positive tumor expression as defined in the protocol\n* Have at least one \"target lesion\" to be used to assess response as defined by RECIST v1.1\n* Patients must have received prior treatment with ≤ 3 prior lines of therapy for recurrent disease; hormonal agents are not considered a line of therapy; prior treatment with folate receptor-targeting investigational agents is not allowed\n* Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Time from prior therapy: Systemic anti-neoplastic therapy: five half-lives or four weeks, whichever is shorter; Radiotherapy: wide-field radiotherapy completed at least four weeks, or focal radiation completed at least two weeks, prior to starting study treatment\n* Patients must have resolution of toxic effect(s) of the most recent prior chemotherapy\n* Patients must have adequate hematologic, liver and kidney function as defined in the protocol\n* Women of child bearing potential (WCBP), must agree to use effective contraceptive methods during study treatment and for at least twelve weeks after the last dose of IMGN853\n* WCBP must have a negative pregnancy test within 4 days prior to the first dose of study treatment\n* At time of initial surgery, patient may have either been optimally or suboptimally debulked\n* Have signed the informed consent form, and willing to adhere to the study visit schedule and other protocol requirements\n* ≥ 18 years of age\n\nExclusion Criteria:\n\n* Active or chronic corneal disorder\n* Serious concurrent illness or clinically-relevant active infection as defined in the protocol\n* Clinically-significant cardiac disease such as recent myocardial infarction (≤ 6 months prior to day 1), unstable angina pectoris, uncontrolled congestive heart failure, uncontrolled hypertension, prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled cardiac arrhythmias, clinically-significant vascular disease, severe aortic stenosis, clinically significant peripheral vascular disease, or cardiac toxicity following prior chemotherapy\n* History of neurological conditions\n* History of hemorrhagic or ischemic stroke within the last 6 months\n* History of cirrhotic liver disease\n* Previous clinical diagnosis of non-infectious pneumonitis\n* Prior hypersensitivity to monoclonal antibodies\n* Women who are pregnant or breast feeding\n* Carcinomatous meningitis, untreated central nervous system (CNS) disease or symptomatic CNS metastasis\n* History or evidence of thrombotic or hemorrhagic disorders within 6 months before first study treatment\n* Required used of folate-containing supplements (e.g. folate deficiency)\n* Has a known additional malignancy that is progressing or required active treatment within 3 years of first dose of study treatment","100 Years",{"count":527,"type":20},[56],"The purpose of this study is to evaluate the activity and safety profile of mirvetuximab soravtansine (IMGN853) in patients with type II endometrial cancers that overexpress folate receptor alpha (FRα).",[26],{"date":297,"type":37},{"date":578,"type":37},"2020-07-15",{"date":132,"type":20},{"name":581,"class":44},"Alessandro Santin",{"id":583,"slug":4,"hasResults":11,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":21,"phases":591,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":615},"100592106","NCT06989112","DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+\u002F2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer","DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+\u002F2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer","DE-01","* Key Inclusion Criteria:\n\n  * Participants must be ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations.\n  * Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies are allowed except for sarcomas (carcinosarcomas are allowed).\n  * Following surgery or diagnostic biopsy, participant must have primary advanced disease (Stage III\u002FIV) or first recurrent endometrial cancer and meet at least one of the following criteria:\n\n    * Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator's assessment.\n    * Primary Stage IV disease (per FIGO 2023) regardless of presence of measurable disease at baseline.\n    * First recurrent disease regardless of presence of measurable disease at baseline.\n  * Endometrial cancer with HER2 IHC expression of 3+ or 2+ as assessed by prospective central testing.\n  * Endometrial cancer that is determined pMMR by prospective central IHC testing.\n  * Provision of adequate FFPE tumor tissue sample of a tumor lesion that was not previously irradiated for central HER2, MMR, and PD-L1 IHC testing and valid central test results for randomization\u002F stratification.\n  * Prior therapy:\n\n    * Naïve to first-line systemic anticancer therapy. Participants may have received one prior line of adjuvant\u002Fneoadjuvant chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred ≥ 6 months after last dose of chemotherapy. Prior trastuzumab in the adjuvant\u002Fneoadjuvant setting is allowed.\n    * No prior exposure to ADCs or immune checkpoint inhibitors including (but not limited to) anti-PD-1\u002FPD-L1\u002FPD-L2 and anti-CTLA-4 antibodies and therapeutic anticancer vaccines.\n    * Participants may have received prior radiation therapy for the treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic\u002Fpara-aortic radiation therapy, and\u002For intravaginal brachytherapy. Adequate treatment washout period is required.\n  * Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.\n  * Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days before randomization.\n  * Adequate organ and bone marrow function within 14 days before randomization.\n* Key Exclusion Criteria:\n\n  * History of organ transplant\n  * Uncontrolled intercurrent illness, including, but not limited to ongoing or active known infection, serious chronic gastrointestinal conditions associated with diarrhea and active non-infectious skin disease requiring systemic treatment.\n  * Spinal cord compression or clinically active central nervous system metastases\n  * Participants with a medical history of myocardial infarction (MI) within 6 months before randomization, or symptomatic congestive heart failure (CHF) (NYHA Class II to IV), clinically significant arrhythmia, or cardiomyopathy of any etiology. Participants with troponin levels above ULN at screening (as defined by the manufacturer), should have a cardiologic consultation before enrollment to rule out MI\n  * History of (non-infectious) ILD\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n  * Lung criteria:\n\n    * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion etc.).\n    * Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n    * Prior pneumonectomy (complete).\n  * Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n  * Active primary immunodeficiency\u002F active infectious disease(s) including:\n\n    * Tuberculosis (TB)\n    * HIV infection that is not well controlled.\n    * Chronic or active hepatitis B, chronic or active hepatitis C; however, participants who have chronic hepatitis B and are receiving suppressive antiviral therapy are allowed to be enrolled if alanine aminotransferase (ALT) is normal and viral load is controlled.\n  * Any concurrent anticancer treatment without an adequate washout period prior to the first dose of study intervention. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., HRT) is allowed.",{"count":590,"type":20},600,[247],"DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and\u002For T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+\u002F2+), pMMR, primary advanced (Stage III\u002FIV) or recurrent EC.",[26],[26,595,416,251,596,597,598,599,600,601,602,255,603,604,605,606,607],"Uterine Cancer","PMMR","Trastuzumab deruxtecan","T-DXd","DS-8201a","Anti-HER2-Antibody Drug Conjugate(ADC)","DESTINY-Endometrial01","Programmed Cell Death-1 (PD1, PD-1)","TIGIT","Pembrolizumab","Carboplatin","Paclitaxel","Rilvegostomig","2026-06-19",{"date":530,"type":37},{"date":611,"type":37},"2025-03-27",{"date":613,"type":20},"2031-02-19",{"name":206,"class":135},250,{"id":617,"slug":4,"hasResults":11,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":21,"phases":624,"briefSummary":625,"conditions":626,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":638},"100580714","NCT06840886","A Study of PHST001 in Advanced Solid Tumors","An Open-label, Phase 1a\u002F1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and\u002For Refractory Solid Tumors","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.\n* Adequate organ function per laboratory testing\n* Pregnancy prevention requirements\n* Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator\u002Fradiology\n* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale\n\nKey Exclusion Criteria:\n\n* Diagnosis of immunodeficiency\n* History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.\n* Active known CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks by repeat imaging \\[note that the repeat imaging should be performed during study screening\\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n* Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Received previous treatment with another agent targeting CD24.",{"count":623,"type":20},272,[119],"This is a multi-center, first-in-human (FIH), open-label, Phase 1a\u002F1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and\u002For refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and\u002For refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.",[627,95,26,628,629],"Advanced Solid Tumors","Cholangiocarcinoma","CNS Tumor","2026-06-18",{"date":530,"type":37},{"date":633,"type":37},"2025-03-31",{"date":635,"type":20},"2031-04",{"name":637,"class":135},"Pheast Therapeutics",20,{"id":640,"slug":4,"hasResults":11,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":21,"phases":647,"briefSummary":648,"conditions":649,"keywords":650,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":663},"100337626","NCT03675893","RESOLVE: Abemaciclib + Letrozole +\u002F- Metformin or Gedatolisib in Endometrial Cancer","RESOLVE: A Multi-Cohort Phase 2 Study of Letrozole\u002FAbemaciclib Alone and in Combination With Metformin and Gedatolisib","Inclusion Criteria:\n\n* Participants must have cytologically or histologically confirmed endometrial cancer that is recurrent or metastatic and\u002For resistant to standard therapies, or for which no standard therapy is available. Participants enrolled in the second stage of Cohort 1A, or into Cohort 3, 6 and 7, must have histologically confirmed either i) endometrioid endometrial cancer or ii) endometrial carcinosarcoma with endometrioid epithelial component\n* Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC). If multiple analyses have been performed, judgment should be based on the most recent biopsy or pathology specimen analyzed in a CLIA-certified laboratory.\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.\n* Age ≥ 18 years\n* ECOG performance status of 0 or 1\n* Participants must have normal organ and bone marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelets ≥ 100,000\u002FmcL\n  * Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin \\\u003C\u002F= 2.0 times ULN and direct bilirubin within normal limits are permitted.\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3× institutional ULN\n  * Creatinine ≤ 1.5 × institutional ULN, OR\n  * Creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels above institutional normal.\n* For cohorts 6 and 7, patients must not have remaining ovarian function to be included. Women who have ovarian function are eligible but must be placed on hormonal suppression.\n* The effects of the study agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of study agent. Contraceptive methods may include an intrauterine device (IUD) or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. A negative serum pregnancy test is required for study entry from women of childbearing potential.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Ability to swallow and retain oral medication.\n* Participants can have received an unlimited number of prior therapies.\n* Participants must have archival tissue available for analysis in the form of a formalin-fixed paraffin embedded (FFPE) block or unstained slides. Note: confirmation of availability of archival tissue is the only requirement for eligibility, archival tissue does not need to be received by the study team prior to enrollment\n* For Cohorts 6 and 7, participants must have HbA1c ≤6.4% and fasting plasma glucose (FPG) ≤140 mg\u002FdL.\n* For Cohort 6 and 7, patients must have wildtype TP53 as assessed either by immunohistochemistry or any CLIA-certified next-generation sequencing assay.\n* For Cohort 7, patients must have received prior CDK4\u002F6 inhibitor therapy and developed disease progression as deemed by the investigator. Patients who have stopped CDK4\u002F6 inhibitor therapy because of intolerance are ineligible.\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy, immune therapy, other investigational therapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study medication. Previous hormonal therapy, including prior letrozole, is allowed and there is no required washout period for hormonal therapy.\n* Participants who have had tyrosine kinase inhibitor (TKI) therapy within 5 half-lives of study entry.\n* Participants who have had radiation therapy within 2 weeks of the first dose of study medication.\n* Participants who have received previous treatment with CDK4\u002F6 inhibitors, including but not limited to previous abemaciclib therapy. For Cohort 7, patients must have received prior treatment with CDK4\u002F6 inhibitors.\n* Participants who are currently receiving metformin therapy (if enrolling to Cohort 3).\n* Participants who have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs\n* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents that the participant will be administered.\n* Participants who at the time of study enrollment are known to require concomitant therapy with moderate or strong CYP3A4 inducers, or strong inhibitors of CYP3A4. Due to potential drug interactions, concomitant use of these medications is not permitted for the duration of treatment on trial. Participants are eligible for study entry if an appropriate substitution is made prior to the first dose of study medication.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Use of known QT-prolonging drugs during screening or expected requirement for use during study therapy.\n* Participants with histories or evidence of cardiovascular risk including any of the following: acute coronary syndromes (i.e. myocardial infarction or angina), coronary angioplasty, or stenting within 6 months prior to study enrollment.\n* Pregnant women are excluded from this study because the study agents are anti-cancer agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding must be discontinued if the mother is treated on trial.\n* Individuals with a history of a different malignancy are ineligible with the following exceptions: individuals who have been treated and are disease-free for a minimum of 5 years prior to study enrollment, or individuals who are deemed by the treating investigator to be at low risk for disease recurrence. Additionally, individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: basal or squamous cell carcinomas of the skin, and breast or cervical carcinomas in situ.\n* Known HIV-positive participants are ineligible because of the increased risk of lethal infections when treated with marrow-suppressive therapy.\n* Participants with a history of uncontrolled hypertension despite optimal medical management, defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 90 mmHg.\n* For Cohorts 6 and 7: Inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF\\>480 msec (determined by mean of triplicate ECGs at screening).\n* For Cohorts 6 and 7, participants with type 1 diabetes or uncontrolled type 2 diabetes.\n* For Cohorts 6 and 7, participants who have previously received any PI3K pathway inhibitors are ineligible. Up to 10 patients in Cohort 6 and up to 10 patients in Cohort 7 may have received prior mTOR inhibitor therapy such as everolimus.",{"count":646,"type":20},110,[56],"This research study is studying a combination of targeted therapies as a possible treatment for estrogen-receptor positive (ER+) endometrial cancer.\n\nThe drugs involved in this study are:\n\n* Abemaciclib (also known as Verzenio™)\n* Letrozole (also known as Femara®)\n* Metformin (also known as Glucophage®)\n* Gedatolisib (also known as PF-05212384)",[26],[26,651,652,653,154,654],"CDK4\u002F6","ER+","Estrogen Receptor","PAM",{"date":656,"type":37},"2026-06-22",{"date":658,"type":37},"2018-12-24",{"date":660,"type":20},"2031-08-01",{"name":662,"class":44},"Dana-Farber Cancer Institute",3,{"id":665,"slug":4,"hasResults":11,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":670,"targetDuration":4,"studyType":21,"phases":671,"briefSummary":672,"conditions":673,"keywords":679,"overallStatus":689,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":692,"completionDateStruct":693,"leadSponsor":695,"locationsCount":4},"100644293","NCT07664735","A Phase 1 Study to Evaluate the Safety and Efficacy of OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.","A Phase 1a\u002Fb Study to Evaluate the Safety and Efficacy of OPB 201, an Autologous PReferentially Expressed Antigen of MElanoma (PRAME) T Cell Receptor (TCR) T Cell Therapy in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.","Inclusion Criteria:\n\n1. Age ≥ 18 years of age at the time of signing the informed consent form.\n2. Histologically confirmed diagnosis of endometrial cancer, epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.\n3. Received at least 1 prior line of systemic chemotherapy including a platinum-based chemotherapy.\n4. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1\u002F2 mutation.\n5. Measurable disease.\n6. Consent to provide archived tumor tissue sample.\n7. ECOG performance status of 0 or 1.\n8. Adequate organ function.\n9. HLA-A \\*02:01 or HLA-A \\*02:02\n10. PRAME positive tumor\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breastfeeding.\n2. Uncontrolled bacterial, fungal, or viral infections.\n3. Active infection requiring systemic therapy.\n4. Bleeding or thrombotic disorders or at risk for severe hemorrhage.\n5. Any form of primary immunodeficiency.\n6. Had an allogenic tissue\u002Fsolid organ transplant.\n7. Active autoimmune disease.\n8. Concurrent treatment with systemic high dose corticosteroids.\n9. Unresolved acute effects of any prior therapy.\n10. Other exclusions as stated in the protocol.",{"count":19,"type":20},[119],"The goal of this clinical trial is to learn if OPB-201 is safe in recurrent endometrial and platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-201. Participants will have their own T cells modified in a laboratory and given back to them as OPB-201 in this one-time treatment. Participants will be in the hospital when they receive OPB-201 and then be checked at the clinical site frequently for the first few months.",[674,26,675,95,676,677,678],"Endometrial Cancer Recurrent","Advanced Endometrial Cancer","Ovarian Cancer Recurrent","Platinum Resistant Ovarian Cancer","Endometrial Cancers",[680,681,682,683,684,685,686,687,688],"Outpace","Ovarian cancer","Endometrial cancer","advanced ovarian cancer","advanced endometrial cancer","cell therapy","TCR-T","TCR","PRAME directed TCR","NOT_YET_RECRUITING","2026-06-17",{"date":424,"type":37},{"date":127,"type":20},{"date":694,"type":20},"2030-09",{"name":696,"class":135},"Outpace Bio, Inc.",{"id":698,"slug":4,"hasResults":11,"nctId":699,"briefTitle":700,"officialTitle":701,"acronym":702,"eligibilityCriteria":703,"healthyVolunteers":11,"sex":16,"minAge":704,"maxAge":4,"enrollmentInfo":705,"targetDuration":4,"studyType":21,"phases":707,"briefSummary":708,"conditions":709,"keywords":710,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":717,"startDateStruct":718,"completionDateStruct":720,"leadSponsor":722,"locationsCount":724},"100608354","NCT07200466","Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation","ENDORISK Clinical Implementation Study","ENDORISK-I","Inclusion Criteria:\n\n* Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)\n* Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* No understanding of Dutch or English language\n* Rare types of endometrial cancer, such as endometrial stroma cell sarcoma","45 Years",{"count":706,"type":20},735,[23],"Rationale: Preoperative identification of patients at risk for lymph node metastasis (LNM) is challenging in endometrial cancer (EC). Therefore, a Bayesian network model called ENDORISK was developed and validated in three external cohorts to improve preoperative risk stratification. The next step is to implement and evaluate whether use of the model improves daily clinical practice. Objective: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate whether implementation of ENDORISK in daily clinical practice improves preoperative risk stratification. Study design: A stepped wedge non inferiority study in which two oncology regions will consecutively start implementation of ENDORISK with one year interval. The ENDORISK model will be filled in and used in preoperative treatment counselling. Results will be compared to current standard clinical care which is prospectively evaluated in both regions since March 2022 in the 'evaluation of care in endometrial cancer' study (2021-7400). Study population: all consecutive patients recently diagnosed with early stage EC who are eligible for surgical treatment, who understand Dutch and are able to fill in a digital or paper questionnaire can be included. Main study parameters\u002Fendpoints: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate implementation of ENDORISK in daily clinical practice by investigating:\n\n* The proportion of identified LNM in patients with lymph node staging (positive predictive value (PPV)) compared to standard care\n* Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care\n* Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care\n* Patients' disease- specific-, overall survival, and health-related quality of life compared to standard care\n* Patients' and doctors' use of and experiences with the ENDORISK-model\n* Impact of ENDORISK on regional care costs",[26],[711,26,712,713,714,715,716],"ENDORISK","surgical staging","risk stratification","lymph node metastases","lymphadenectomy","sentinel node",{"date":656,"type":37},{"date":719,"type":37},"2025-10-23",{"date":721,"type":20},"2032-10-16",{"name":723,"class":44},"Radboud University Medical Center",14,{"id":726,"slug":4,"hasResults":11,"nctId":727,"briefTitle":728,"officialTitle":729,"acronym":4,"eligibilityCriteria":730,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":731,"targetDuration":4,"studyType":21,"phases":733,"briefSummary":734,"conditions":735,"keywords":742,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":764,"startDateStruct":765,"completionDateStruct":767,"leadSponsor":769,"locationsCount":771},"100370548","NCT04104776","A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","A Phase 1\u002F2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","Key Inclusion Criteria:\n\nAll Patients:\n\n* Adults aged ≥18 years with life expectancy ≥12 weeks\n* ECOG performance status 0-1\n* Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)\n* Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds\n* Willingness to provide tumor tissue and blood samples for biomarker analyses\n* Agreement to protocol-specified contraception requirements\n* Signed informed consent prior to study procedures\n\nDisease-Specific Inclusion Criteria:\n\nPhase 1 (Dose Escalation):\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma\n* Disease refractory to standard therapy or with no available effective standard treatment\n* For prostate cancer: castrate testosterone levels maintained throughout the study\n\nPhase 2 (Disease-Specific Cohorts):\n\n* M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)\n* M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)\n* M3: ARID1A mutant recurrent\u002Fmetastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy\n* M4: Relapsed\u002Frefractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease\n* M5: Relapsed\u002Frefractory pleural or peritoneal mesothelioma with documented BAP1 loss\n* M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy\n* M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)\n* M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure\n\nKey Exclusion Criteria:\n\nAll Patients:\n\nMedical Conditions:\n\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Active or untreated symptomatic CNS metastases (with limited exceptions)\n* Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled infections or significant gastrointestinal disorders affecting absorption\n* Active HIV or hepatitis B\u002FC infection\n* Concurrent malignancy requiring active treatment (with protocol-defined exceptions)\n* Pregnancy, breastfeeding, or inability to comply with protocol requirements\n\nPrior or Concomitant Therapy:\n\n* Recent anticancer therapy within protocol-defined washout periods\n* Prior EZH2 inhibitor treatment\n* Recent radiation or liver-directed therapies outside allowed windows\n* Use of strong CYP3A4\u002F5 inhibitors or inducers\n\nAdditional Cohort-Specific Exclusions:\n\n* M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies\n* M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease",{"count":732,"type":20},275,[119,56],"The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.",[466,736,737,738,739,26,740,741],"Diffuse Large B Cell Lymphoma","Lymphoma, T-Cell","Mesothelioma, Malignant","Prostatic Neoplasms, Castration-Resistant","Ovarian Clear Cell Carcinoma","Metastatic Castration-resistant Prostate Cancer",[743,744,745,746,747,748,749,750,751,752,753,754,755,756,757,758,759,26,740,760,761,762,763],"Tulmimetostat","DZR123","Lymphoma, Large B-Cell, Diffuse","Lymphoma, B-cell","Lymphoma, T-cell","Lymphoma, Non-Hodgkin","Lymphoma","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Topoisomerase Inhibitors","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents","Food effect","Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)","ARID1A wildtype (ARID1A WT) endometrial carcinoma","Metastatic castration-resistant prostate cancer (mCRPC)",{"date":656,"type":37},{"date":766,"type":37},"2019-09-18",{"date":768,"type":20},"2030-02-27",{"name":770,"class":135},"Novartis Pharmaceuticals",81,{"id":773,"slug":4,"hasResults":11,"nctId":774,"briefTitle":775,"officialTitle":776,"acronym":4,"eligibilityCriteria":777,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":276,"enrollmentInfo":778,"targetDuration":4,"studyType":21,"phases":780,"briefSummary":781,"conditions":782,"keywords":784,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":790,"lastUpdatePostDateStruct":791,"startDateStruct":792,"completionDateStruct":794,"leadSponsor":796,"locationsCount":797},"100476843","NCT05489211","Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)","A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced\u002FMetastatic Solid Tumours","Key Inclusion Criteria: There are additional substudy requirements not reflected here. This list is based solely on the master CSP\n\n* Male and female, ≥ 18 years\n* Documented advanced or metastatic malignancy\n* Eastern Cooperative Oncology Group performance status of 0 or 1 with no deterioration over the 2 weeks prior to baseline or day of first dosing\n* All participants must provide a tumour sample for tissue-based analysis\n* At least 1 measurable lesion not previously irradiated, except Substudy 3 (Prostate Cancer) which allows participants with non measurable bone metastatic disease\n* Adequate bone marrow reserve and organ function\n* Minimum life expectancy of 12 weeks\n* At the time of screening, contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* All women of childbearing potential must have a negative serum pregnancy test documented during screening\n* Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control. Female participants must not donate, or retrieve for their own use, ova at any time during this study\n* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile, avoid intercourse, or use a highly effective method of contraception. Male participants must not freeze or donate sperm at any time during this study.\n* Capable of giving signed informed consent\n* Provision of signed and dated written optional genetic research informed consent prior to collection of samples for optional genetic research that supports the Genomic Initiative\n\nKey Exclusion Criteria:\n\n* Any evidence of diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol\n* History of another primary malignancy except for adequately resected basal cell carcinoma or in situ squamous cell carcinoma of the skin, or other solid malignancy treated with curative intent\n* Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved\n* Irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the investigator, for example hearing loss\n* Spinal cord compression or brain metastases unless treated\n* Leptomeningeal carcinomatosis\n* Clinically significant corneal disease\n* Active hepatitis or uncontrolled hepatitis B or C virus infection\n* Uncontrolled infection requiring IV antibiotics, antivirals or antifungals, for example prodromal symptoms\n* Known HIV infection that is not well controlled\n* Known active tuberculosis infection\n* Mean resting corrected QTcF \\> 470 ms\n* In the judgement of the investigator, history of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause TdP\n* In the judgement of the investigator, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives\n* Uncontrolled or significant cardiac diseases\n* History of non-infectious Interstitial lung disease (ILD)\u002Fpneumonitis, including radiation pneumonitis that required steroids\n* Has severe pulmonary function compromise\n* Prior exposure to chloroquine\u002Fhydroxychloroquine without an adequate treatment washout period\n* Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention\n* Prior exposure to anticancer therapies without an adequate treatment washout period prior to enrolment or any concurrent anticancer treatment\n* Palliative radiotherapy with a limited field of radiation within ≤ 2 weeks or to more than 30% of the bone marrow within ≤ 4 weeks before the first dose of study intervention\n* Major surgical procedure or significant traumatic injury within ≤ 3 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Prior treatment with TROP2-directed therapies or other antibody-drug conjugate (ADCs) with deruxtecan payload\n* Herbal or natural products intended as treatment or prophylaxis for any type of cancer that may interfere with the activity of the study intervention\n* Previous treatment in the present study\n* Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study\n* Severe hypersensitivity to Dato-DXd or any of the excipients, including but not limited to polysorbate 80 or other monoclonal antibodies\n* Involvement in the planning and\u002For conduct of the study\n* Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements\n* Females that are pregnant, breastfeeding, or planning to become pregnant\n* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of Dato-DXd",{"count":779,"type":20},454,[56],"TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced\u002FMetastatic Solid Tumours.",[26,90,741,95,195,222,783],"Biliary Tract Cancer",[785,786,787,788,789],"TROPION-PanTumor03","Datopotamab Deruxtecan (Dato-DXd)","Solid Tumours","Antibody-drug conjugate (ADC)","Trophoblast cell surface protein 2 (TROP2)","2026-06-16",{"date":690,"type":37},{"date":793,"type":37},"2022-09-06",{"date":795,"type":20},"2027-10-01",{"name":206,"class":135},96,{"id":799,"slug":4,"hasResults":11,"nctId":800,"briefTitle":801,"officialTitle":802,"acronym":4,"eligibilityCriteria":803,"healthyVolunteers":11,"sex":76,"minAge":17,"maxAge":4,"enrollmentInfo":804,"targetDuration":4,"studyType":21,"phases":806,"briefSummary":807,"conditions":808,"keywords":811,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":790,"lastUpdatePostDateStruct":813,"startDateStruct":814,"completionDateStruct":816,"leadSponsor":818,"locationsCount":819},"100448747","NCT05123482","A Phase I\u002FIIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced\u002FMetastatic Solid Malignancies","A Phase I\u002FIIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Relapsed\u002Fmetastatic solid tumors treated with prior adequate standard of care therapy for tumor type and stage of disease or where in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and\u002For tolerability to prior therapy.\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Life expectancy ≥ 12 weeks\n* Adequate bone marrow, hepatic, and renal function as defined in the protocol\n\nAdditional Inclusion Criteria For Sub-Study 1 Part A:\n\n• Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, ovarian cancer, BTC or endometrial cancer\n\nAdditional Inclusion Criteria For Sub-Study 1 Part B:\n\n* Histologically or cytologically confirmed metastatic or locally advanced and recurrent disease for the respective cohort:\n\n  1. Cohort B1 (Biliary Tract Cancer)\n  2. Cohort B2 (Ovarian Cancer)\n  3. Cohort B3 (Breast Cancer)\n  4. Cohort B4 (Endometrial Cancer)\n  5. Cohort B5 (Squamous Non-Small Cell Lung Cancer)\n\n     Additional Inclusion Criteria For Sub-Study 2 Part A:\n* Minimum body weight ≥ 30 kg.\n* Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.\n\nAdditional Inclusion Criteria For Sub-Study 3 Part A:\n\n* Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).\n* Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.\n\nAdditional Inclusion Criteria For Sub-Study 4 Part A:\n\n* Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).\n* Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, endometrial cancer or squamous non-small cell lung cancer.\n* Participants must have progressed following at least one but no more than 3 prior lines of treatment for metastatic or relapsed disease and have no satisfactory alternative treatment option as judged by the Investigator.\n\nKey Exclusion Criteria:\n\n* Treatment with any of the following:\n\n  1. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment\n  2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment\n  3. Any other anticancer treatment within the following time periods prior to the first dose of study intervention:\n\n     1. Cytotoxic treatment: 21 days\n     2. Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)\n     3. Biological products including immuno-oncology agents: 28 days\n* Spinal cord compression or a history of leptomeningeal carcinomatosis.\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \\> 10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to start of study.\n* Active infection including tuberculosis and HBV, HCV or HIV\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Participants with any of the following cardiac criteria:\n\n  1. History of arrhythmia which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation, or asymptomatic sustained ventricular tachycardia.\n  2. Uncontrolled hypertension.\n  3. Acute coronary syndrome\u002Facute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months.\n  4. History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.\n  5. Symptomatic heart failure (NYHA class ≥ 2).\n  6. Prior or current cardiomyopathy.\n  7. Severe valvular heart disease.\n  8. Mean resting QTcF \\> 470 msec.\n  9. Risk factors for QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.\n* Patients with history of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML (as determined by prior diagnostic investigation)\n\nAdditional Exclusion Criteria For Sub-Study 2 Part A:\n\n* Thromboembolic event within 3 months before the first dose of study intervention - No longer applicable per amendment 7\n* Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* History of organ transplant\n\nAdditional Exclusion Criteria For Sub-Study 2 Part B\n\n• Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)\n\nAdditional Exclusion Criteria For Sub-Study 3 Part A:\n\n* Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers\u002Finhibitors.\n* Any history of persisting (\\> 2 weeks) severe cytopenia due to any cause\n* Patients with any known predisposition to bleeding\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib.\n* Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)\n\nAdditional Exclusion Criteria For Sub-Study 4 Part A:\n\n* Patients have received prior therapy with AZD9574 or more than 1 prior line of any other PARPi-based regimen\n* Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers\u002Finhibitors.\n* Previous treatment with rilvegostomig for the cohort treated with rilvegostomig\n* Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9574",{"count":805,"type":20},460,[119,56],"This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents",[85,809,95,26,810],"Biliary Tract Carcinoma","Squamous Non-Small Cell Lung Cancer",[812],"First In Human, antibody drug conjugate, cancer, solid tumour, Phase I, Phase IIa",{"date":690,"type":37},{"date":815,"type":37},"2021-10-18",{"date":817,"type":20},"2027-09-29",{"name":206,"class":135},67,""]