[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622185":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":45,"studyPopulation":45,"armGroups":52,"interventions":74,"overallOfficials":45,"centralContacts":80,"locations":86,"responsibleParty":113,"collaborators":45,"id":115,"slug":45,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":45,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":45,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":45,"overallStatus":89,"whyStopped":45,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Jiangsu HengRui Medicine Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":45},[9,13,17,19,23],{"measure":10,"description":11,"timeFrame":12},"The incidence and severity of dose-limiting toxicity (DLT).","The first dosing cycle after each subject's enrollment is the DLT observation period.","Expected results within one year.",{"measure":14,"description":15,"timeFrame":16},"Adverse events (AEs).","Continuous observation from each participant's knowledge until the end of the safety follow-up period.","Approximately 12 months after the last patient enrolled.",{"measure":18,"description":15,"timeFrame":16},"Serious adverse events (SAEs).",{"measure":20,"description":21,"timeFrame":22},"Maximum tolerated dose (MTD).","Based on the preliminary data summary evaluation, it is estimated that after completing the dose group ramping up and expanding the efficacy of 1-2 cohorts into the group with preliminary efficacy results, corresponding results can be obtained.","Plan to obtain results within 10 months of the first dose ramp up.",{"measure":24,"description":21,"timeFrame":25},"Recommended dose for phase II clinical study (RP2D).","Plan to obtain results within 20 months of the first dose ramp up.",[27,31,34,37,39,41,43],{"measure":28,"description":29,"timeFrame":30},"Pharmacokinetics (PK) indicator - Blood drug concentration.","The plan is to conduct an evaluation within 4 weeks after each dose escalation and within 4 weeks after each dose expansion. The PK evaluation of efficacy expansion needs to be evaluated based on specific preliminary data as appropriate.","The plan is to complete all evaluations within 2 years.",{"measure":32,"description":33,"timeFrame":30},"Immunogenic indicator - Anti-drug antibody (ADA) levels.","The plan is to conduct an evaluation within 4 weeks after each dose escalation and within 4 weeks after each dose expansion. The ADA evaluation of efficacy expansion needs to be evaluated based on specific preliminary data as appropriate.",{"measure":35,"description":36,"timeFrame":16},"Effectiveness indicator - Researchers evaluated objective response rate (ORR).","After the first medication, imaging examinations should be conducted every 6 weeks (±7 days) for the first 36 weeks and every 9 weeks (±7 days) thereafter, and follow-up should be continued until the subject's imaging progress.",{"measure":38,"description":36,"timeFrame":16},"Effectiveness indicator - Researchers evaluated duration of response (DoR).",{"measure":40,"description":36,"timeFrame":16},"Effectiveness indicator - Researchers evaluated disease control rate (DCR).",{"measure":42,"description":36,"timeFrame":16},"Effectiveness indicator - Researchers evaluated progression free survival (PFS).",{"measure":44,"description":36,"timeFrame":16},"Effectiveness indicator - Researchers evaluated overall survival (OS) based on the RECIST v1.1 evaluation criteria for solid tumor treatment efficacy.",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":49,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":51,"maskingDescription":45,"whoMasked":45},"NONE",[53,59,62,65,68,71],{"label":54,"type":55,"description":56,"interventionNames":57},"SHR-1049 Group - Queue 1","EXPERIMENTAL","Specified dose on specified days.",[58],"Drug: SHR-1049 Injection",{"label":60,"type":55,"description":56,"interventionNames":61},"SHR-1049 Group - Queue 2",[58],{"label":63,"type":55,"description":56,"interventionNames":64},"SHR-1049 Group - Queue 3",[58],{"label":66,"type":55,"description":56,"interventionNames":67},"SHR-1049 Group - Queue 4",[58],{"label":69,"type":55,"description":56,"interventionNames":70},"SHR-1049 Group - Queue 5",[58],{"label":72,"type":55,"description":56,"interventionNames":73},"SHR-1049 Group - Queue 6",[58],[75],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":45},"DRUG","SHR-1049 Injection","SHR-1049 injection.",[54,60,63,66,69,72],[81],{"name":82,"role":83,"phone":84,"phoneExt":45,"email":85},"Peng Xiu","CONTACT","+86-0518-82342973","peng.xiu@hengrui.com",[87],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"The First Affiliated Hospital of College of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":96,"coordinates":97},"Point",[98,99],120.16142,30.29365,{"lat":99,"lon":98},[102,106,110,112],{"name":103,"role":83,"phone":104,"phoneExt":45,"email":105},"Tingbo Liang","+86-0571-87236688","liangtingbo@zju.edu.cn",{"name":107,"role":83,"phone":108,"phoneExt":45,"email":109},"Xueli Bai","+86-0571-87236857","shirleybai@zju.edu.cn",{"name":103,"role":111,"phone":45,"phoneExt":45,"email":45},"PRINCIPAL_INVESTIGATOR",{"name":107,"role":111,"phone":45,"phoneExt":45,"email":45},{"type":114,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100622185",false,"NCT07380334","A Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 in Patients With Advanced Solid Tumors","An Open Label, Multicenter Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1049 Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with follow-up;\n2. Age range of 18-75 years old (including 18 and 75 years old, calculated on the day of signing informed consent), both male and female are eligible;\n3. Dose exploration stage: Participants with advanced or metastatic solid tumors diagnosed by tissue or cytological pathology who have failed standard treatment (disease progression or toxicity intolerance) or have no effective standard treatment;\n4. Stage of efficacy extension: Late stage or metastatic solid tumors diagnosed by tissue or cytological pathology;\n5. Able to provide sufficient fresh or archived tumor tissue specimens for third-party central laboratories designated by the sponsor to test expression levels; For participants who are unable to provide tumor tissue samples, the decision to enroll will be made after joint evaluation by the researchers and the sponsor;\n6. At least one measurable lesion that meets RECIST v1.1 criteria; Lesions that have undergone local treatment, if there is clear evidence of significant progression after treatment, can be selected as target lesions;\n7. ECOG PS score: 0 to 1;\n8. Expected survival period ≥ 12 weeks;\n9. The function of important organs meets the requirements;\n10. Female participants with fertility must have a negative serum HCG test within 7 days prior to their first medication and must be non lactating; Female participants with fertility must agree to use contraception and avoid egg donation for a period of 7 months from the signing of the informed consent form until the last administration of the investigational drug; Male participants whose partners are fertile women must agree to contraception and avoid donating sperm for a period of 4 months from the signing of the informed consent form until the last administration of the investigational drug.\n\nExclusion Criteria:\n\n1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis; Participants with a history of meningeal metastasis or current meningeal metastasis;\n2. Imaging shows tumor invasion of large blood vessels or unclear boundary with blood vessels; Or it may be determined by researchers that the participant's tumor has a high possibility of invading important blood vessels and causing fatal massive bleeding during treatment;\n3. Previous or concurrent presence of other malignant tumors;\n4. Chest effusion, pericardial effusion, or abdominal effusion that is accompanied by clinical symptoms, difficult to control, or moderate or above; If fluid drainage is performed (excluding diagnostic puncture surgery), those who have been stable for at least 2 weeks after drainage can be included in the group;\n5. Interstitial pneumonia\u002Finterstitial lung disease, non infectious pneumonia (such as radiation pneumonitis) that previously required steroid treatment; Currently present or suspected of having interstitial pneumonia\u002Finterstitial lung disease, non infectious pneumonia, or other active pneumonia; Severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, and other lung damage occurred within 6 months prior to the first use of medication; Individuals with active pulmonary tuberculosis;\n6. Accompanied by poorly controlled or severe cardiovascular disease;\n7. Within one month prior to the first medication, there has been a bleeding event with NCI-CTCAE v5.0 grade ≥ 2;\n8. Those who have experienced or are expected to experience gastrointestinal perforation or fistula, tracheal fistula, urethral fistula, or abdominal abscess within 3 months before the first medication;\n9. Symptoms and signs of gastrointestinal obstruction or gastrointestinal obstruction within 3 months prior to the first use of medication;\n10. Participants who have experienced a severe infection within one month prior to their first medication;\n11. History of immunodeficiency, including HIV test positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Participants known to have active hepatitis or active hepatitis C;\n12. Patients who have previously undergone surgery (excluding diagnostic surgery), radiotherapy, local treatment, chemotherapy, macromolecular targeted therapy, anti-tumor immunotherapy, and have completed treatment (last medication) less than 4 weeks after the first medication; Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) with less than 5 half lives or 4 weeks (whichever is shorter) between the last dose and the first dose;\n13. Previously received drug treatment with the same mechanism as the experimental drug;\n14. According to NCI-CTCAE v5.0 classification, those whose toxicity caused by previous anti-tumor therapy has not yet recovered to ≤ grade 1;\n15. Individuals known to be allergic to any component or other antibody drugs of SHR-1049 product;\n16. Those who have received attenuated live vaccine within 4 weeks before the first administration or are likely to receive attenuated live vaccine during treatment and within 60 days after the last administration;\n17. According to the researcher's judgment, there are other factors that may affect the research results or force the termination of this study midway.","ALL","18 Years","75 Years",{"count":125,"type":126},200,"ESTIMATED","INTERVENTIONAL",[129],"PHASE1","This study is a multicenter, open label, dose exploration\u002Fefficacy extension Phase I clinical trial aimed at evaluating the safety, tolerability, pharmacokinetics and efficacy of SHR-1049 injection in patients with advanced solid tumors.",[132],"Advanced Solid Tumor","2026-04-15",{"date":135,"type":136},"2026-04-16","ACTUAL",{"date":138,"type":136},"2026-03-12",{"date":140,"type":126},"2028-12",{"name":5,"class":6},1]