[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dmmr-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dmmr-cancer":190},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,80,106],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100560701",false,"NCT06580574","Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR\u002FMSI-H Gastric or Colon Cancers","PD-1\u002FPD-L1 Antibody With Selective Combination of Sintilimab, IBI310 and Lenvatinib Used for Organ Preservation in Non-metastatic Gastric or Colon Cancers With Mismatch Repair Deficiency or High Microsatellite Instability","Inclusion Criteria:\n\n* Subjects are able to comprehend the informed consent form, and voluntarily sign the informed consent form.\n* Subjects are ≥18 years old on the day of signing the informed consent form, with no gender restrictions.\n* Histologically confirmed gastric cancer or colon cancer, without distant metastasis based on CR or MR.\n* ECOG performance status of 0-2.\n* dMMR confirmed by immunohistochemistry or MSI-H confirmed by PCR and NGS. If MSI status and MMR status were not consistent, whether to enroll this patient should be determine by investigators. Patients with MMR heterogeneity in tumors could not be included.\n* Patients who are about to receive or are receiving 24 weeks of PD1\u002FPDL1 antibody monothearpy and have not had the first efficacy assessment.\n* Archived tumor tissue samples or freshly obtained tumor tissue samples are available.\n* Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception from 7 days before the first dose until 120 days after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose.\n* Subjects have the ability and willingness to comply with the study protocol's visits, treatment plan, laboratory tests, and other study-related procedures.\n* For patients who are about to receive combination of Sintilimab, IBI310 and Lenvatinib. subjects should have good organ function within the first 7 days of initial dosing: HGB ≥ 80g\u002FL, NEU ≥ 1.0\\*10\\^9\u002FL, PLT ≥ 75\\*10\\^9\u002FL, Cr≤1.5×ULN or CrCl≥50mL\u002Fmin（Cockcroft-Gault method), TBiL ≤ 1.5×ULN, ALT and AST ≤3 ×ULN; urine protein \\\u003C2+; if urine protein ≥ 2+, 24 hour urinary protein quantity \\\u003C2g; INR, APTT, PT ≤ 1.5 ×ULN\n\nExclusion Criteria:\n\n* Distant metastasis;\n* Previous treatment including CTLA4 blockade;\n* Subjects with interstitial lung disease or a history of non-infectious pneumonia requiring oral or intravenous corticosteroid treatment.\n* Subjects with active autoimmune diseases requiring systemic treatment before the start of the study or those considered at risk of recurrence or planned treatment for autoimmune diseases as judged by the investigator. Except for these conditions: a) skin diseases that do not require systemic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); b) hypothyroidism caused by autoimmune thyroiditis, requiring stable doses of hormone replacement therapy; c) type 1 diabetes requiring stable doses of insulin replacement therapy; d) childhood asthma fully resolved with no need for intervention in adulthood; e) the investigator judges that the disease will not relapse without external triggering factors.\n* Subjects with a history of other malignant tumors within 5 years, excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-invasive bladder carcinoma, localized low-risk prostate cancer (defined as stage ≤T2a, Gleason score ≤6, and prostate-specific antigen (PSA) ≤10 ng\u002FmL (if measured) in patients who have undergone curative treatment and have no biochemical recurrence of prostate-specific antigen (PSA)), in situ cervical\u002Fbreast carcinoma, or Lynch syndrome.\n* Subjects with uncontrolled comorbidities, including but not limited to: a) active HBV or HCV infection; b) subjects who are HBsAg positive and\u002For HCV antibody positive during screening must undergo HBV DNA and\u002For HCV RNA testing. Only subjects with HBV DNA ≤500 IU\u002FmL (or ≤2000 copies\u002FmL) and\u002For HCV RNA negative can be enrolled; HBV DNA monitoring will be at the discretion of the investigator based on the subject's condition during the trial; c) known HIV infection or AIDS history; d) active tuberculosis; e) uncontrolled hypertension (resting blood pressure ≥160\u002F100 mmHg), symptomatic congestive heart failure (NYHA II-IV), unstable angina or myocardial infarction within 6 months, or the presence of QTc prolongation or the risk of arrhythmia (baseline QTc \\>470 msec \\\u003CFridericia method correction\\>, refractory hypokalemia, long QT syndrome, atrial fibrillation with resting heart rate \\>100 bpm, or severe valvular heart disease); f) active bleeding that cannot be controlled after medical treatment.\n* History of allogeneic bone marrow or organ transplantation.\n* Previous history of allergic reactions, hypersensitivity reactions, or intolerance to antibody drugs (e.g., severe allergic reactions, immune-mediated hepatotoxicity, immune-mediated thrombocytopenia, or anemia).\n* Pregnant and\u002For lactating females.\n* For patients who are about to receive combination of Sintilimab, IBI310 and Lenvatinib: a) Subjects with a history of gastrointestinal perforation or fistula within 6 months before the first dose. If the perforation or fistula has been treated with resection or repair, and the disease is judged to be recovered or improved by the investigator, then enrollment is allowed. b) Subjects who have undergone major surgery within 28 days before the first dose (e.g., major abdominal or thoracic surgery; excluding drainage, diagnostic puncture, or peripheral vascular access replacement). c) Subjects who require systemic corticosteroids (≥10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy for a continuous 7-day period within 14 days before the first dose. Inhaled or locally applied steroids and physiological replacement doses of steroids due to adrenal insufficiency are allowed. Short-term (≤7 days) corticosteroids for prophylaxis (e.g., contrast dye allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reaction caused by exposure to allergens) are allowed. d) Toxicity from previous antitumor treatments has not recovered to Grade ≤2 (NCI-CTCAE v5.0) or baseline, except for alopecia, skin pigmentation (allowed at any level), and immune-related adverse reactions requiring physiological replacement (e.g., hypothyroidism, hypopituitarism, type 1 diabetes).","ALL","18 Years",{"count":18,"type":19},34,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This study intends to explore the role of PD1\u002FPDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR\u002FMSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability",[25,26,27,28],"Gastric Cancer","Colon Cancer","MSI-H","DMMR Cancer",[30,31,32],"Organ preservation","immunotherapy","anti-VEGF","RECRUITING","2026-05-13",{"date":36,"type":37},"2026-05-15","ACTUAL",{"date":39,"type":37},"2024-09-13",{"date":41,"type":19},"2029-06-01",{"name":43,"class":44},"Peking University","OTHER",1,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100590952","NCT06974110","Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors","A Phase 1 Study of MOMA-341 as Monotherapy or Combination Therapy in Participants With Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease. Participants must have previously received and progressed on an anti-PD-(L)1-based regimen, unless ineligible or in a region without access to anti-PD-(L)1 therapies\n3. Have at least 1 lesion at baseline (measurable or non-measurable) suitable for repeat imaging evaluation by RECIST and\u002For PCWG-3\n4. ECOG PS ≤ 2\n5. Fully recovered from clinically relevant effects of prior therapy, radiotherapy, and\u002For surgery \\*\\*hormonal therapy allowed. Palliative radiotherapy allowed\n6. Adequate organ function per local labs\n7. Comply with contraception requirements\n8. Written informed consent must be obtained according to local guidelines\n\nExclusion Criteria:\n\n1. Known Werner Syndrome\n2. Active prior or concurrent advanced-stage malignancy (some exceptions allowed including early-stage cancers)\n3. Clinically relevant cardiovascular disease\n4. Known CNS metastasis associated with progressive neurological symptoms (stable doses of corticosteroids allowed)\n5. Known active uncontrolled infection\n6. Known allergy, hypersensitivity, and\u002For intolerance to MOMA-341\n7. Impaired GI function that may impact absorption\n8. Patient is pregnant or breastfeeding\n9. Known to be HIV positive, unless all of the following criteria are met:\n\n   1. Undetectable viral load or CD4+ count ≥300 cells\u002FμL\n   2. Receiving highly active antiretroviral therapy\n   3. No AIDS-related illness within the past 12 months\n10. Active liver disease (some exceptions are allowed)\n11. Prior or ongoing condition, therapy, or laboratory abnormality that, in the investigator's opinion, may affect safety of the patient, confound the results of the study, and\u002For interfere with the patients participation in the study",{"count":53,"type":19},132,[55],"PHASE1","This Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.",[58,59,60,61,62,25,63],"Advanced Solid Tumor","Metastatic Solid Tumor","Endometrial Cancer","MSI-H Cancer","Colorectal Cancer","dMMR Cancer",[65,66,67,68,58,59,25,62,60,61,63],"Phase 1","MOMA-341","Werner helicase","WRN","2026-04-14",{"date":71,"type":37},"2026-04-15",{"date":73,"type":37},"2025-07-16",{"date":75,"type":19},"2028-05",{"name":77,"class":78},"MOMA Therapeutics","INDUSTRY",14,{"id":81,"slug":4,"hasResults":10,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":10,"sex":87,"minAge":16,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":20,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":45},"100621760","NCT07374809","IMMUNOTHERAPY EFFICACY TARGETING ENDOMETRIAL CANCER","DISSECTING THE EPIGENOME AND MICROENVIRONMENT TO UNDERSTAND IMMUNOTHERAPY EFFICACY TARGETING ENDOMETRIAL CANCER (DEMETER PROJECT)","DEMETER","Inclusion Criteria:\n\n* Female patients ≥ 18 years old.\n* Histologically confirmed epithelial endometrial carcinoma (endometrioid, serous, clear cell, mixed, or carcinosarcoma).\n* Advanced (stage III-IV) or recurrent disease, eligible for surgery or biopsy as part of the therapeutic plan.\n* Availability of fresh-frozen or OCT-embedded tumor tissue obtained at surgery\u002Fbiopsy and stored in the IEO Biobank.\n* Mismatch-repair-deficient (dMMR) or -proficient (pMMR) molecular subtype (when available).\n* Written informed consent for participation and use of biological material for translational research purposes.\n\nExclusion Criteria:\n\n* Mesenchymal tumors or epithelial tumors of non-endometrial origin (e.g., ovarian, cervical).\n* Prior systemic treatment with immune checkpoint inhibitors for other malignancies.\n* Insufficient or poor-quality tumor tissue available for molecular analyses.\n* Active or uncontrolled infection with HIV, HBV, or HCV.\n* Any condition that, in the investigator's judgment, would compromise patient safety or study integrity.","FEMALE","120 Years",{"count":90,"type":19},50,[92],"NA","Endometrial carcinoma (EC) represents the most common gynecological malignancy in developed countries. Despite therapeutic advances, patients with advanced or recurrent disease still have a poor prognosis, with high recurrence rates and a 5-year survival of less than 20%.\n\nRecently, four phase III studies (RUBY, NRG-GY018, AtTEnd, and DUO-E) have demonstrated that the addition of anti-PD-1\u002FPD-L1 immunotherapy to first-line chemotherapy significantly improves progression-free survival, particularly in tumors with altered DNA repair mechanisms known as mismatch repair (MMR) (so-called mismatch repair-deficient or dMMR tumors), but with benefits also observed in a subset of tumors with normal MMR function (so-called MMR-proficient or pMMR tumors). However, despite the clinical approval of these therapies, reliable biomarkers capable of predicting response to immunotherapy are still lacking.\n\nThis project aims to comprehensively characterize the genomic, epigenetic, and lipid properties of the tumor and the tumor microenvironment (TME) in order to identify predictive markers of response to immunotherapy, thereby laying the foundation for a personalized therapeutic approach in endometrial carcinoma.",[95,96,28],"Endometrial Carcinoma (EC)","pMMR","NOT_YET_RECRUITING","2026-01-21",{"date":100,"type":37},"2026-01-29",{"date":98,"type":19},{"date":103,"type":19},"2027-11-30",{"name":105,"class":44},"European Institute of Oncology",{"id":107,"slug":4,"hasResults":10,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":20,"phases":115,"briefSummary":116,"conditions":117,"keywords":150,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100445919","NCT05086692","A Beta-only IL-2 ImmunoTherapY Study","A Phase 1\u002F2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors","ABILITY-1","Key Inclusion Criteria:\n\n1. Aged at least 18 years (inclusive at the time of informed consent).\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n3. Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)\n5. Demonstrated adequate organ function\n6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and\u002For MRI.\n7. Life expectancy of ≥ 12 weeks.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.\n9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.\n\nKey Exclusion Criteria:\n\n1. Last administration of prior antitumor therapy:\n\n   * Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.\n   * Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\\\u003C2 weeks of radiotherapy) to non-CNS disease.\n   * Radiation therapy to the lung that is \\> 30Gy within 6 months prior to start of treatment.\n   * Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.\n2. Has known active CNS metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 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 start of treatment, subject to discussion with MM.\n3. Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.\n4. Condition requiring long-term systemic treatment with either corticosteroids \\> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.\n5. Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.\n6. Severe pulmonary, cardiac or other systemic disease.\n7. Known hepatitis B or C virus infection.\n8. Females who are pregnant or lactating or planning to become pregnant during the study.\n9. Has had an allogeneic tissue\u002Fsolid organ transplant.\n10. Active infection requiring systemic therapy.\n11. Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol\n12. Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.\n13. Known severe hypersensitivity to any component of study drug(s).\n14. Inability to comply with study and follow up procedures as judged by the Investigator.",{"count":114,"type":19},115,[55,22],"This is a Phase 1\u002F2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.",[58,118,119,120,121,122,123,25,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,61,28,146,147,148,149,60],"Unresectable Solid Tumor","Clear Cell Renal Cell Carcinoma","Triple Negative Breast Cancer","Non-Small Cell Lung Cancer Squamous","Non-Small Cell Lung Cancer Non-squamous","Colorectal Cancer (MSI-H)","Cervical Cancer","Basal Cell Carcinoma","Bladder Cancer","Merkel Cell Carcinoma","Squamous Cell Carcinoma of Head and Neck","Cutaneous Squamous Cell Carcinoma","Pleural Mesothelioma","Esophageal Cancer","Endometrial Carcinoma","Solid Tumor","Solid Tumor, Adult","MSI-H Solid Malignant Tumor","Cancer With A High Tumor Mutational Burden","Epithelial Ovarian Carcinoma","Primary Peritoneal Cancer","Gastroesophageal Junction (GEJ) Cancer","Acral Melanoma","Mucosal Melanoma","Cutaneous Melanoma","DMMR Solid Malignant Tumor","Fallopian Tube Cancer","Ovarian Cancer","Pancreas Adenocarcinoma (MSI-H)","Skin Cancer","Viral Cancer","Cervical Cancers",[151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,27,169,170,171,172,31,173,174,175,176,177,178,179],"IL-2","IL2","Interleukin-2","cancer","metastatic","ccRCC","TNBC","NSCLC","CRC","GEJ","intrahepatic","extrahepatic","MCC","SCCHN","CSCC","Gastroesophageal Junction","advanced","unresectable","dMMR","Microsatellite Instability-High","Mismatch Repair Deficient","PD-1","anti-PD-1","BCC","RCC","HCC","Tumor Mutation Burden High","TMB-H","PDAC","2025-07-03",{"date":182,"type":37},"2025-07-09",{"date":184,"type":37},"2021-08-27",{"date":186,"type":19},"2026-12-30",{"name":188,"class":78},"Medicenna Therapeutics, Inc.",27,""]