[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Hengrui Pharmaceutical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":535},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,40,63,86,109,130,150,170,191,211,232,253,274,294,316,334,355,375,394,415,435,455,474,495,515],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100630664","phase-1-a-phase-i-study-of-shr-3836-in-patients-with-multiple-myeloma-100630664",false,"NCT07490613","A Phase I Study of SHR-3836 in Patients With Multiple Myeloma","An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3836 in Patients With Multiple Myeloma","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female\n2. Expected survival ≥ 3 months\n3. ECOG performance status 0 or 1\n4. Diagnosed with active multiple myeloma per IMWG criteria\n5. Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy.\n6. Disease progression or non-response to the most recent therapy\n7. Measurable disease as defined by serum\u002Furine M-protein or serum free light chain\n8. Adequate bone marrow, hepatic, renal, and coagulation function\n9. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception\n10. Willing and able to provide written informed consent and comply with study procedures\n\nExclusion Criteria:\n\n1. Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.\n2. Central nervous system involvement by tumor.\n3. History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.\n4. Requirement for dialysis or plasmapheresis within 14 days prior to study drug.\n5. Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).\n6. Concurrent participation in another clinical study.\n7. Prior anti-tumor therapy within specified washout periods.\n8. Major surgery within 28 days prior to informed consent or planned during the study.\n9. Live attenuated vaccine within 4 weeks prior to first dose or planned during the study.\n10. Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.\n11. Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo).\n12. Active infection.\n13. Known hypersensitivity or contraindication to SHR-3836.","ALL","18 Years",{"count":20,"type":21},99,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-3836 in patients with multiple myeloma (MM).",[27],"Multiple Myeloma","RECRUITING","2026-06-02",{"date":31,"type":32},"2026-06-04","ACTUAL",{"date":29,"type":32},{"date":35,"type":21},"2029-04",{"name":37,"class":38},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":39},"100565985","phase-3-shr-a1904-compared-with-investigators-choice-of-therapy-in-claudin182-positive-patitens-with-second-line-advanced-or-metastatic-gastric-or-gastroesophageal-junction-adenocarcinoma-100565985","NCT06649292","SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","An Open, Randomized,Positive Control, Multicenter Phase III Clinical Study of SHR A1904 for Injection Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patients With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Age 18 to 75 years old (including boundary values)\n2. Volunteer to participate in this clinical study and sign informed consent;\n3. ECOG score 0-1;\n4. Expected survival ≥3 months;\n5. Gastric or Gastroesophageal Junction Adenocarcinoma;\n6. positive CLDN18.2 expression in tumor tissue;\n7. There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;\n8. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study\n2. HER2 posotive (IHC 3+ or IHC 2+\u002FISH +);\n3. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;\n4. Individuals with Leptomeningeal metastasis or Active brain metastases;\n5. Individuals with a history of GI perforation or fistula, unstable GI bleeding;\n6. Individuals with a history of severe cardiovascular and cerebrovascular diseases;\n7. The researcher determined that there are other situations that are not suitable for participation.","75 Years",{"count":49,"type":21},524,[51],"PHASE3","The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC\u002FGEJC patients",[54],"Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","2026-05-12",{"date":57,"type":32},"2026-05-15",{"date":59,"type":32},"2024-11-22",{"date":61,"type":21},"2028-03-20",{"name":37,"class":38},{"id":64,"slug":65,"hasResults":12,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100552543","phase-1-a-phase-ibii-clinical-study-of-shr-9839-for-injection-combined-with-other-anti-tumor-therapies-in-patients-with-advanced-solid-tumors-100552543","NCT06474455","A Phase IB\u002FII Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors","A Phase IB\u002FII, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Aged 18-75 years old (inclusive), regardless of gender.\n2. Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer.\n3. At least one measurable tumor lesion according to RECIST v1.1.\n4. ECOG performance score of 0-1.\n5. Life expectancy ≥ 12 weeks.\n6. Adequate bone marrow and organ function.\n7. Have the ability to informed consent, have signed the IRB \u002F EC approved informed consent and dated, willing and able to comply with the treatment plan to visit the inspection and other procedural requirements.\n\nExclusion Criteria:\n\n1. Patients with active central nervous system ( CNS ) metastases.\n2. Spinal cord compression not be cured by surgery or radiotherapy.\n3. Subjects with uncontrollable tumor-related pain.\n4. Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion.\n5. Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.\n6. Received \\> 30 Gy chest radiotherapy within 24 weeks prior to the first dose of study drug.\n7. Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug.\n8. Concomitant other malignancies ≤ 3 years prior to the first dose of study drug.\n9. History of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis or inability to exclude interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function.\n10. Serious cardiovascular and cerebrovascular diseases.\n11. Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug.\n12. History of immunodeficiency, including HIV test positive.\n13. Active hepatitis B or hepatitis C infection.\n14. History of severe allergic reactions to any component of any study drug to be accepted.\n15. Known history of alcohol or drug dependence.\n16. Mental disorders or poor compliance.\n17. Pregnant or lactating women.\n18. Patients with any active, known or suspected autoimmune disease.\n19. Patients received systemic immunostimulatory therapy within 4 weeks before starting the study, or received systemic immunosuppressive therapy within 2 weeks before starting the first study.\n20. Patients who had previously used immune checkpoint inhibitors were not allowed to be enrolled in this study if they had a CTCAE grade 3 immune-related adverse event that lasted for 4 weeks or more, or a CTCAE grade 4 immune-related adverse event.",{"count":71,"type":21},156,[24,73],"PHASE2","This study is an open-label, multicenter Phase IB\u002FII clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.",[76],"Advanced Solid Tumors","2026-05-05",{"date":79,"type":32},"2026-05-11",{"date":81,"type":32},"2024-07-02",{"date":83,"type":21},"2029-12",{"name":37,"class":38},2,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":39},"100616109","phase-1-a-study-of-single-and-multiple-doses-of-hrs-6257-in-healthy-subjects-100616109","NCT07301333","A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects","A Phase 1 Study To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Food on the Bioavailability of HRS-6257 in Healthy Subjects","Inclusion Criteria:\n\n1. Aged between 18 and 55 years old (based on the time of signing the informed consent form), both males and females are eligible.\n2. The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 28 kg\u002Fm².\n3. Female subjects must be non-pregnant or non-childbearing potential;\n4. Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.\n\nExclusion Criteria:\n\n1. History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease;\n2. Known or suspected hypersensitivity to trial product(s) or related products;\n3. 12-lead ECG demonstrating QTcF \\>450 msec or history or risk factors for QT prolongation;\n4. Blood donation of more than 200 mL within the last 6 months\n5. Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 7 half-lives;\n6. Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse.\n7. Previous administration with an investigational product (drug or vaccine) within 3 months;",true,"55 Years",{"count":96,"type":21},80,[24],"This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.",[100],"Pain","2026-04-01",{"date":103,"type":32},"2026-04-07",{"date":105,"type":32},"2025-12-30",{"date":107,"type":21},"2026-05",{"name":37,"class":38},{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":39},"100598595","phase-1-phase-iii-clinical-study-of-shr-1501-combined-with-adbelizumab-in-patients-with-malignant-tumors-100598595","NCT07073534","Phase I\u002FII Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors","Phase I\u002FII Clinical Study on the Tolerability, Safety and Efficacy of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in person.\n2. Age: 18 to 75 years old (including both ends), gender not limited.\n3. Subjects with locally advanced or metastatic solid tumors that have been histologically or cytologically confirmed to be inoperable for radical surgery or radical chemoradiotherapy, whose disease progresses after standard treatment, or who have no standard treatment plan, or are not suitable for standard treatment.\n4. According to the efficacy evaluation criteria for Solid tumors (RECIST 1.1), there is at least one measurable lesion;\n5. The ECOG physical condition score is 0 or 1.\n6. The expected survival time is more than 3 months;\n\nExclusion Criteria:\n\n1. Symptomatic or active central nervous system (CNS) tumor metastasis;\n2. Other malignant tumors within five years before the first use of study drugs;\n3. Uncontrolled tumor-related pain judged by the investigator;\n4. Severe cardiovascular and cerebrovascular diseases;\n5. Significant clinical bleeding symptoms within 3 months before the first study drug, and obvious fresh hemoptysis within 1 month before the first study drug;\n6. Uncontrollable pleural effusion and\u002For ascites judged by the study or pleural effusion and\u002For ascites requiring intervention within 7 days before the first treatment\n7. History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-related pneumonia requiring steroid therapy;,or active pneumonia at screening; or other moderate to severe pulmonary diseases that significantly affect pulmonary function;\n8. Severe infection within 4 weeks before the start of study treatment\n9. History of immunodeficiency\n10. Used corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other systemic immunosuppressants within 14 days before the first study drug.\n11. Patients with active pulmonary tuberculosis infection within 1 year before enrollment as determined by medical history or imaging examination, or patients with a history of active pulmonary tuberculosis infection more than 1 year ago but without formal treatment\n12. Patients whose adverse events caused by previous treatment have not recovered to ≤CTCAE grade 1\n13. Patients whose previous treatment washout does not meet the following requirements: Patients who have received chemotherapy, biological therapy, targeted therapy, immunotherapy, or other unlisted clinical research drugs and other anti-tumor treatments within 4 weeks before the first use of the study drug\n14. Patients who have experienced CTCAE grade 4 or grade 3 immune-related adverse events lasting for 4 weeks or longer after previous use of immune checkpoint inhibitors, or immune-related adverse events that led to treatment discontinuation, are not eligible for enrollment in this study.\n15. Patients who have received \\>30 Gy chest radiotherapy within 24 weeks before the first use of the study drug, patients who have received \\>30 Gy non-chest radiotherapy within 4 weeks before the first use of the drug (subjects who have completed brain metastasis radiotherapy 14 days before the first use of the drug can be enrolled), and patients who have received ≤30 Gy within 14 days before the first use of the drug Gy of palliative radiation;\n16. Subjects who have undergone surgery on important organs (excluding puncture biopsy) within 4 weeks before the first use of the study drug, have had significant trauma, or need to undergo elective surgery during the trial;\n17. Active, known or suspected autoimmune diseases and history of autoimmune diseases.\n18. Using attenuated live vaccines within 28 days before the first use of the study drug, or anticipating the need to use attenuated live vaccines during the study treatment;\n19. Pregnant or lactating women or female subjects who plan to become pregnant during the study and within 6 months after the last use of the study drug;\n20. Those who are known to be allergic to any component or excipient of the study drug; or have a history of severe allergic reactions to other monoclonal antibodies\u002Ffusion protein drugs;\n21. The investigators judge that the subjects have other factors that may affect the study results or force the termination of this study, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious abnormal laboratory test values, family or social factors, and other situations that may affect the safety of the subjects or the collection of trial data.",{"count":117,"type":21},203,[24,73],"This study is an open, multicenter phase I\u002FII clinical study. The entire study is divided into three stages: dose escalation, dose expansion, and efficacy expansion. Objective: To evaluate the objective response rate (ORR), safety and tolerability of the combination of SHR-1501 and adibelizumab in the treatment of advanced malignant tumors, and to provide the recommended dose (RP2D) for subsequent clinical studies.",[121],"Patients With Advanced or Metastatic Malignant Tumors","2026-01-20",{"date":124,"type":32},"2026-01-22",{"date":126,"type":32},"2025-07-24",{"date":128,"type":21},"2027-12",{"name":37,"class":38},{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":149,"locationsCount":39},"100615725","phase-1-hrs-4642-combination-with-other-antitumor-therapies-in-patients-with-solid-tumors-100615725","NCT07296341","HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors","A Phase IB\u002FII Study To Evaluate the Safety, Tolerability, and Preliminary Efficacy of HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors","Inclusion Criteria:\n\n1. Age range of 18-75 years old (inclusive of both ends), gender not limited when signing the informed consent form\n2. ECOG performance status 0 or 1\n3. Life expectancy of greater than or equal to 12 weeks.\n4. Subjects with unresectable local advanced or metastatic pancreatic cancer, and pancreatic duct adenocarcinoma confirmed by histopathology\n5. Provide tumor tissue blocks fixed in formalin, embedded in paraffin, or unstained tumor specimen sections, which can be archived or freshly obtained within 3 years prior to the first study treatment (fresh acquisition is preferred).\n6. At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)\n\nExclusion Criteria:\n\n1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis\n2. Failure to recover toxicity and\u002For complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria\n3. Subjects known or suspected to have interstitial pneumonia\n4. According to the common adverse reaction event evaluation criteria NCI-CTCAE v5.0, patients with ≥ grade 3 serous fluid accumulation or imaging evidence of a large amount of abdominal fluid accumulation (those who require therapeutic puncture and drainage within 2 weeks before starting the study treatment, only those with imaging showing a small amount of ascites and no clinical symptoms can be enrolled)\n5. Acute or chronic pancreatitis with significant clinical significance",{"count":138,"type":21},60,[24,73],"This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors",[142],"Locally Advanced or Metastatic Pancreatic Cancer With","2026-01-13",{"date":145,"type":32},"2026-01-14",{"date":147,"type":32},"2026-01-08",{"date":128,"type":21},{"name":37,"class":38},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":85},"100613549","phase-2-a-trial-of-shr-7787-injection-combined-with-other-anti-tumor-drugs-in-patients-with-malignant-solid-tumors-100613549","NCT07268040","A Trial of SHR-7787 Injection Combined With Other Anti-tumor Drugs in Patients With Malignant Solid Tumors","A Multicenter, Open-label Phase II Clinical Study of SHR-7787 Combined With Other Antitumor Drugs in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;\n2. Patients with histologically or cytologically confirmed unresectable solid tumors;\n3. At least one measurable lesion was identified per RECIST 1.1;\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n5. Adequate organ functions as defined per protocol;\n6. Minimum life expectancy of 3 months.\n\nExclusion Criteria:\n\n1. Patients with known active central nervous system (CNS) metastases;\n2. History of other malignancy within the past 5 years, with exceptions defined in the protocol;\n3. Patients with uncontrolled cancer pain;\n4. Patients with serious cardiovascular and\u002For cerebrovascular diseases;\n5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;\n6. Patients with Severe infections within 4 weeks prior to the first dose;\n7. Active pulmonary tuberculosis infection;\n8. History of immunodeficiency;\n9. History of autoimmune diseases;\n10. The adverse events of previous antineoplastic therapy did not recover to CTCAE≤ grade 1;\n11. Pregnant or nursing women, or planned to become pregnant during the study period;\n12. Known allergic to any component of investigational drugs.",{"count":158,"type":21},400,[73],"This study aims to evaluate the safety, tolerability and efficacy of SHR-7787 in combination with other anti-tumor drugs in patients with malignant solid tumors.",[162],"Malignant Solid Tumors",{"date":164,"type":32},"2026-01-12",{"date":166,"type":32},"2025-12-23",{"date":168,"type":21},"2028-12",{"name":37,"class":38},{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":39},"100542987","phase-1-shr-a1904-combinations-in-cldn182-positive-advanced-solid-tumor-100542987","NCT06350006","SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor","A Phase Ib\u002FIII Study of SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor","Inclusion Criteria:\n\n1. Age 18 to 75 years old (including boundary values);\n2. Volunteer to participate in this clinical study and sign informed consent;\n3. ECOG score 0-1;\n4. Expected survival ≥3 months;\n5. Pathologically confirmed locally advanced unresectable or metastatic solid tumors;\n6. positive CLDN18.2 expression in tumor tissue;\n7. There is at least one measurable lesion that meets the RECIST 1.1 criteria;\n8. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Plan to receive any other antitumor therapy during this trial; Received other investigational drugs or treatments that are not on the market within 4 weeks prior to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before the first administration of the study drug. Palliative radiotherapy or local therapy within 2 weeks before the first administration of the study drug; Had major surgery other than diagnosis or biopsy within the 4 weeks prior to the first administration or randomization and required elective surgery during the trial.\n2. HER2 expression in tumor tissue is positive.\n3. The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE v5.0 grade≤ 1.\n4. Has ≥ grade 2 peripheral sensory neuropathy.\n5. Has an allergic reaction to any of the components treated in this study, or are allergic to humanized monoclonal antibody products.\n6. Has a history or current history of meningeal metastasis; or active brain metastases.\n7. Presence of dysphagia or other factors affecting the use of oral medications.\n8. Additional malignancy within the five years prior to the first administration or randomization.\n9. Has an active autoimmune disease or a history of autoimmune disease.\n10. Received systemic use of corticosteroids or other immunosuppressants for immunosuppressive effects within 14 days prior to the first administration or randomization.\n11. Has a history of clinically significant lung disease.\n12. Has serosal effusion ≥ grade 3 (based on NCI CTCAE5.0 criteria).\n13. There was an active infection requiring systemic treatment within 2 weeks prior to the first administration or randomization.\n14. A history of immunodeficiency, including a positive HIV test; Presence of active hepatitis B or hepatitis C.\n15. People who have previously received allogeneic hematopoietic stem cell transplantation or organ transplantation.\n16. Has severe cardiovascular and cerebrovascular diseases.\n17. Gastrointestinal perforation and\u002For gastrointestinal fistula within the last 6 months prior to the first administration or randomization; Active gastrointestinal bleeding occurred 3 months before the first administration or randomization.\n18. In the investigator's judgment, the subject has other factors that could have affected the study results or led to the forced termination of the study.",{"count":178,"type":21},924,[24],"This study consists of two research phases:\n\nPhase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.\n\nPhase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.",[182],"CLDN18.2-positive Advanced Solid Tumor","2025-12-25",{"date":185,"type":32},"2025-12-31",{"date":187,"type":32},"2024-05-29",{"date":189,"type":21},"2028-12-30",{"name":37,"class":38},{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":210,"locationsCount":39},"100610592","phase-1-a-study-of-shr-7367-with-anti-tumor-agents-in-patients-with-solid-tumors-100610592","NCT07229586","A Study of SHR-7367 With Anti-tumor Agents in Patients With Solid Tumors","A Phase IB\u002FII Clinical Study of the Safety, Tolerability and Efficacy of SHR-7367 in Combination With Anti-tumor Agents in Subjects With Solid Tumors","Inclusion Criteria:\n\n1. Be able and willing to provide a written informed consent.\n2. Age 18-75 years old (inclusive) at the time of signing the informed consent form.\n3. ECOG performance status 0-1.\n4. Life expectancy is not less than 12 weeks.\n5. At least one measurable lesion per RECIST v1.1.\n6. Adequate organ and marrow function as defined by the protocol.\n\nExclusion Criteria:\n\n1. Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures.\n2. Known hypersensitivity to any component of SHR-7367; History of severe allergic reactions to other monoclonal antibodies\u002Ffusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination.\n3. Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose).\n4. Surgery or chemotherapy within 4 weeks of the first dose of study treatment.\n5. Active HBV\u002FHCV\u002FHIV infection.\n6. Untreated and\u002For uncontrolled brain metastases.\n7. Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study.",{"count":199,"type":21},100,[24,73],"This study aims to evaluate the safety and preliminary efficacy of SHR-7367 in combination with antineoplastic agents in subjects with advanced solid tumors, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).",[203],"Solid Tumor","2025-12-18",{"date":206,"type":32},"2025-12-19",{"date":208,"type":32},"2025-12-02",{"date":128,"type":21},{"name":37,"class":38},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":39},"100555435","phase-1-a-trial-of-shr-a2102-with-adebrelimab-with-or-without-other-antitumor-therapy-in-advanced-or-metastatic-non-small-cell-lung-cancer-100555435","NCT06512051","A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer","A Phase IB \u002FII, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements.\n2. The age of signing the informed consent is 18 -70 years, regardless of gender.\n3. Provide archived or fresh tumor tissue for vendor test.\n4. At least one measurable lesion according to RECIST v1.1 criteria.\n5. Patients with locally advanced or metastatic non-small cell lung cancer who have been confirmed by histological or cytological examination to be inoperable and unable to undergo radical radiotherapy or chemotherapy.\n6. The ECOG score is 0 or 1.\n7. Expected survival ≥12 weeks.\n8. Good level of organ function.\n9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n1. Active or symptomatic brain metastases.\n2. With the exception of patients diagnosed with any other malignancy, except those who have achieved complete remission at least 5 years prior to screening and have ended adjuvant therapy, can be treated locally and have a clear medical record of cure, such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer in situ, carcinoma in situ of the cervix, breast ductal carcinoma in situ, and papillary carcinoma of the thyroid.\n3. Uncontrollable moderate to large amounts of pleural effusion, peritoneal effusion or pericardial effusion.\n4. Patients with uncontrolled tumor-related pain .\n5. Have antitumor therapy was received 4 weeks before the start of the study.\n6. Perform non-chest radiation therapy with \\>30 Gy within 28 days before dosing, chest radiation therapy with \\>30 Gy within 24 weeks before first dosing, and radiation therapy with ≤30 Gy within 14 days before first dosing.\n7. Subjects who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or the 5 half-life of the investigational drug, whichever is longer.\n8. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period.\n9. Toxicity and\u002For complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria\n10. Systemic immunosuppressive therapy was administered within 14 days prior to the first study.\n11. Subjects with a prior history of interstitial pneumonia\u002Fnon-infectious pneumonia requiring hormone therapy, and currently known or suspected interstitial pneumonia\u002Fnon-infectious pneumonia.\n12. The presence of any active, known or suspected autoimmune disease.\n13. Subjects with severe cardiovascular and cerebrovascular diseases.\n14. Subjects who had a severe infection within 28 days prior to the first dose\n15. Active hepatitis B or active hepatitis C.\n16. Patients with active pulmonary tuberculosis within 1 year prior to enrolment.\n17. Clinically significant bleeding symptoms or significant bleeding tendency occurred within 1 month before the first medication\n18. History of immune deficiency\n19. Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study treatment；\n20. Female subjects who are pregnant or plan to become pregnant during the study period.\n21. Uncontrollable mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.\n22. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.\n23. Having a bleeding tendency, a high risk of bleeding, coagulation dysfunction or thrombosis tendency (for patients using bevacizumab).\n24. Poorly controlled hypertension (with regular antihypertensive treatment, systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg), as well as previous occurrence of hypertensive crisis or hypertensive encephalopathy (in patients using bevacizumab).\n25. Within 6 months prior to the first administration of the medication, had a major vascular disease (for patients using bevacizumab).\n26. If within 7 days prior to the first administration of the drug, the patient had used the full dose of oral or injectable anticoagulant or thrombolytic drugs for therapeutic purposes, prophylactic anticoagulation treatment for the open intravenous infusion system is permitted, and prophylactic use of low-molecular-weight heparin (for patients using bevacizumab) is also allowed.\n27. Within 7 days prior to the first administration, the patient has used or needs to use aspirin, dipyridamole, ticlopidine, clopidogrel, cilostazol or other drugs that inhibit platelet function (for patients using bevacizumab).\n28. Having severe, non-healed wounds, active ulcers or untreated fractures (for patients using bevacizumab).\n29. Within 6 months prior to the first administration of the drug, there had been a history of gastrointestinal perforation. During the screening process, clinical symptoms or signs indicated the presence of intestinal obstruction (for patients using bevacizumab).\n30. CT\u002FMRI indicated that the tumor surrounded or invaded major blood vessels (for patients who received bevacizumab treatment).\n31. Subjects who have previously received systemic treatment with anti-angiogenic drugs such as VEGF\u002FVEGFR inhibitors, including but not limited to bevacizumab, recombinant human endostatin, anlotinib, etc. (patients who used bevacizumab).","70 Years",{"count":220,"type":21},248,[24,73],"The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer.\n\nTo explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer",[224],"Advanced or Metastatic Non-small Cell Lung Cancer","2025-12-16",{"date":166,"type":32},{"date":228,"type":32},"2024-07-30",{"date":230,"type":21},"2026-10",{"name":37,"class":38},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":39},"100610603","phase-2-a-study-of-shr-a2102-in-combination-with-other-anti-tumor-therapies-for-resectable-non-small-cell-lung-cancer-100610603","NCT07229729","A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer","A Randomized, Open-label, Multicenter Phase II Clinical Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Perioperative Treatment of Resectable Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent form in writing;\n2. Participants must be aged between 18 and 70 years old (inclusive) when signing the informed consent form, and both men and women are eligible;\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;\n4. Adequate organ function;\n5. Women of childbearing age must undergo serum pregnancy tests, and the results must be negative. Female subjects of childbearing age and male subjects who are partners of women of childbearing age must agree to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n1. With active, known or suspected autoimmune disease of autoimmune disease;\n2. Malignancies other than NSCLC within 5 years prior to randomization;\n3. Has or suspected has a history of pneumonitis \u002F interstitial lung disease or any serve lung diseases which will influence the examination of lung function;\n4. Significant history of cardiovascular and cerebrovascular disease; Significant haemorrhagic disease;\n5. Has an arteriovenous thrombotic events;\n6. Has a known history of human immunodeficiency virus (HIV) infection;\n7. Has a known active Hepatitis B or Hepatitis C;\n8. Allergic to the intervention regimens.",{"count":240,"type":21},300,[73],"The study is a Phase II study to explore the efficacy and safety of SHR-A2102 in combination with other anti-tumor therapies as perioperative treatment in patients with resectable non-small cell lung cancer.",[244],"Non-small Cell Lung Cancer","2025-11-27",{"date":247,"type":32},"2025-12-01",{"date":249,"type":32},"2025-11-24",{"date":251,"type":21},"2029-10",{"name":37,"class":38},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":39},"100503568","phase-1-the-clinical-study-of-shr-9839-for-injection-in-patients-with-advanced-solid-tumors-100503568","NCT05836948","The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors","An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;\n2. Have at least one measurable tumor lesion per RECIST v1.1;\n3. ECOG performance status of 0-1;\n4. Life expectancy ≥ 12 weeks;\n5. Adequate bone marrow and organ function;\n6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Patients with active central nervous system metastases or meningeal metastases;\n2. Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;\n3. History of serious cardiovascular and cerebrovascular diseases;\n4. Subjects who received\\>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;\n5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.",{"count":261,"type":21},174,[24],"This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.",[265],"Advanced Solid Tumor","2025-08-08",{"date":268,"type":32},"2025-08-11",{"date":270,"type":32},"2023-05-18",{"date":272,"type":21},"2026-06-01",{"name":37,"class":38},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":39},"100493173","phase-1-phase-i-study-of-shr-a2102-in-patients-with-advanced-solid-tumors-100493173","NCT05701709","Phase I Study of SHR-A2102 in Patients With Advanced Solid Tumors","An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of SHR-A2102 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent;\n2. Age ≥18 years old, gender unlimited;\n3. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \\~ 1;\n4. Life expectancy Predicted survival ≥3 months;\n5. Histologically or cytologically confirmed advanced or metastatic malignant tumor; Patients with advanced solid tumors confirmed by pathology who have failed or been intolerant to standard treatment, have no standard treatment or refuse standard treatment;\n6. There is at least one measurable lesion that meets the RECIST 1.1 criteria.\n\nExclusion Criteria:\n\n1. Plan to receive any other antitumor therapy during this trial;\n2. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study drug;\n3. Received antitumor therapy such as chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to first administration of the study drug (nitrosourea or mitomycin C within 6 weeks prior to first administration; Oral fluorouracil within 2 weeks prior to initial first administration); Palliative radiotherapy or local therapy within 2 weeks before first administration use of the study drug;\n4. Had major surgery other than diagnosis or biopsy within 4 weeks prior to the study's initial dosing;\n5. Treatment with CYP3A4, CYP2D6, P-gp or BCRP booster or inducer is less than 5 drug half-life from the date of first administration;\n6. According to NCI-CTCAE v5.0, adverse events caused by previous antitumor therapy did not recover to ≤ grade 1 (except hair loss; In the judgment of the investigator, after consultation with the sponsor, some tolerable chronic grade 2 toxicity may be excluded);\n7. Inadequately treated central nervous system (CNS) metastases, or the presence of uncontrolled or symptomatic active CNS metastases, may be characterized by the presence of clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia meningeal disease, and\u002For rapid progression. Patients with CNS metastases that have been adequately treated and whose neurological symptoms return to baseline at least 4 weeks prior to randomization (except for residual signs or symptoms associated with CNS treatment) may be enrolled. In addition, subjects must either stop corticosteroids or receive prednisone (or an equivalent dose of another corticosteroid) at least 4 weeks prior to randomization;\n8. Any other malignancies, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix, etc. within 5 years prior to initial administration;\n9. A history of clinically significant lung disease (such as interstitial pneumonia, radiation pneumonia, pulmonary fibrosis) or chest imaging during screening suggests any such disease;\n10. Severe infections that require intravenous antibiotic, antiviral or antifungal control;\n11. Active HBV or HCV infection (HBsAg positive and viral copy number ≥2000 IU\u002FmL, HCV antibody positive and HCV RNA higher than the lower limit of detection method);\n12. History of immunodeficiency (including HIV positive, other acquired or congenital immunodeficiency diseases) or organ transplantation;\n13. Concomitant diseases (such as severe diabetes, thyroid disease, and psychosis) or any other conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's ability to complete the study.",{"count":282,"type":21},395,[24],"The study was designed to evaluate the efficacy, safety, and pharmacokinetics of SHR2102 in patients with advanced solid tumors. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of SHR-A2102 in phase II study.",[76],"2025-07-21",{"date":288,"type":32},"2025-07-22",{"date":290,"type":32},"2023-04-06",{"date":292,"type":21},"2025-08-31",{"name":37,"class":38},{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":39},"100572821","phase-3-a-phase-iii-study-of-shr-a2102-versus-investigator-selected-therapy-in-advanced-urothelial-carcinoma-100572821","NCT06738251","A Phase III Study of SHR-A2102 Versus Investigator-selected Therapy in Advanced Urothelial Carcinoma","A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study of SHR-A2102 for Injection Versus Investigator-selected Therapy in Locally Advanced or Metastatic Urothelial Carcinoma Previously Treated With Platinum-Containing Chemotherapy and PD-(L)1 Inhibitors and With or Without ADC","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical study, understand the study procedures and be able to sign the informed consent form in writing.\n2. 18 to 80 years old (including boundary value), gender is not limited.\n3. ECOG performance status score of 0 or 1.\n4. Estimated survival ≥ 3 months.\n5. Pathologically confirmed urothelial carcinoma confirmed by imaging or other methods as locally advanced unresectable or metastatic disease.\n6. Patients with locally advanced or metastatic disease who have previously received both a platinum-based chemotherapy regimen and a PD-(L)1 inhibitor; patients who received platinum-based chemotherapy and\u002For a PD-(L)1 inhibitor as neoadjuvant or adjuvant therapy and experienced recurrence or progression during treatment or within 6 months after completing treatment will be considered to have received these therapies in the locally advanced\u002Fmetastatic setting.\n7. Imaging-confirmed disease progression during or after treatment with the most recent regimen.\n8. Able to provide preserved or fresh tumor tissue.\n9. Must be present with at least one measurable lesion according to RECIST v1.1 criteria.\n10. Good level of organ function.\n11. Male subjects whose partners are women of childbearing potential and female subjects of childbearing potential must use highly effective contraception from the time of signing the informed consent form until 8 months after the last dose of the trial drug.\n\nExclusion Criteria:\n\n1. Planned to receive any other anti-tumor therapy during this trial.\n2. Receipt of other unmarketed clinical trial drugs or treatments within 4 weeks prior to randomization.\n3. Received systemic anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to randomization, and palliative radiotherapy or local therapy within 2 weeks prior to the first use of the investigational drug.\n4. Prior receipt of antibody-drug conjugates containing topoisomerase I inhibitors in the composition.\n5. For locally advanced or metastatic disease: patients who have previously received more than three lines of systemic therapy in this setting.For neoadjuvant or adjuvant therapy: if the disease recurs or progresses during treatment or within 6 months after its completion, the patient is considered to have received first-line systemic therapy for locally advanced or metastatic disease.\n6. Prior treatment with more than 1 antibody-drug conjugate.\n7. Major surgery other than diagnosis or biopsy within 4 weeks prior to randomization that requires elective surgery during the trial.\n8. Received systemic glucocorticoids (prednisone \\> 10 mg\u002Fday or equivalent dose) or other immunosuppressants within 14 days prior to the first use of investigational drug or randomization for immunosuppressive purposes.\n9. Adverse events from prior antineoplastic therapy did not recover to Grade ≤1 according to NCI-CTCAE v5.0.\n10. Inadequately treated central nervous system (CNS) metastases, or the presence of uncontrolled or symptomatic active central nervous system metastases. CNS metastases that have been adequately treated and whose neurological symptoms are able to return to baseline at least 4 weeks prior to randomization (with the exception of residual signs or symptoms associated with CNS treatment) may be enrolled in the study.\n11. Subject has a serous effusion with clinical symptoms or requiring puncture and drainage.\n12. Any malignancy diagnosed within 5 years prior to randomization (calculated from the date of the last anti-tumor treatment), except:Localized, low-risk prostate cancer.Papillary thyroid carcinoma, basal-cell carcinoma, or squamous-cell carcinoma of the skin that has been adequately treated and shows no evidence of disease.Other carcinomas in situ that have been adequately treated and show no evidence of disease recurrence.\n13. History of interstitial pneumonitis\u002Finterstitial lung disease or non-infectious pneumonitis (e.g., radiation pneumonitis) that required systemic corticosteroid therapy.Current evidence, in the investigator's judgment, of uncontrolled interstitial pneumonitis\u002Finterstitial lung disease, non-infectious pneumonitis, or any other active pneumonitis.\n14. Severe infections requiring intravenous antibiotics, antivirals, or antifungals for control.\n15. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n16. Has a history of immunodeficiency or organ transplantation.\n17. Any serious arterial or venous thrombotic event within 6 months before randomization.\n18. Those who have had significant clinically significant bleeding symptoms within 3 months before the first study drug.\n19. Glycosylated hemoglobin (HbA1c) ≥8%.\n20. Have severe cardiovascular and cerebrovascular diseases.\n21. Allergic reaction to any component of this study treatment.\n22. Female subjects who are pregnant or plan to become pregnant during the study.\n23. According to the judgment of the investigator, there are concomitant diseases (such as thyroid disease and mental illness, etc.) or any other conditions that seriously endanger the safety of the patient, or affect the patient's completion of this study.\n24. Prior treatment for urothelial carcinoma with all chemotherapy agents included in the control-arm regimen.","80 Years",{"count":303,"type":21},402,[51],"To evaluate the efficacy and safety of SHR-A2102 for injection versus Investigator-selected Therapy in patients with Locally advanced or Metastatic Urothelial Carcinoma who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors.",[307],"Advanced Urothelial Carcinoma","2025-07-16",{"date":310,"type":32},"2025-07-17",{"date":312,"type":32},"2025-02-12",{"date":314,"type":21},"2027-09",{"name":37,"class":38},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":333,"locationsCount":39},"100584943","phase-2-a-trial-of-shr-a2102-with-other-antitumor-therapies-in-advanced-solid-tumors-100584943","NCT06895928","A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors","A Phase II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. The age of signing the informed consent is 18 -70 years, regardless of gender.\n2. At least one measurable lesion according to RECIST v1.1 criteria.\n3. The ECOG score is 0 or 1.\n4. Expected survival ≥12 weeks.\n5. Good level of organ function.\n6. Have the ability to give informed consent and to comply with the treatment plan.\n7. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.\n2. Spinal cord compression not cured by surgery and\u002For radiotherapy.\n3. Subjects with uncontrolled tumor-related pain.\n4. Received antitumor therapy within 4 weeks before the start of the study.\n5. Subjects with severe cardiovascular and cerebrovascular disease.\n6. History of immunodeficiency, including a positive HIV test.",{"count":158,"type":21},[73],"The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with other antitumor therapies in advanced solid tumors to explore the reasonable dosage, safety and efficacy of SHR-A2102 for advanced solid tumors.",[76],"2025-04-21",{"date":329,"type":32},"2025-04-22",{"date":331,"type":32},"2025-03-28",{"date":168,"type":21},{"name":37,"class":38},{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":39},"100470812","phase-1-a-study-of-shr-1501-alone-or-in-combination-with-bcg-or-shr-1316-in-subjects-with-nmibc-100470812","NCT05410730","A Study of SHR-1501 Alone or in Combination With BCG or SHR-1316 in Subjects With NMIBC","Phase I\u002FII Clinical Study of Dose Escalation and Dose Expansion of SHR-1501 Alone or in Combination With Bacille de Calmette Guerin （BCG） or SHR-1316 in the Treatment of Non-muscle Invasive Bladder Cancer（NMIBC）","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical study, understand the research procedures and be able to sign the informed consent in writing;\n2. Age ≥ 18 years old, gender is not limited;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;\n4. Expected survival time ≥ 2 years;\n5. High-risk NMIBC diagnosed by previous pathological biopsy\n6. Cystoscopy within 6 weeks before the first administration shows that the lesion has been completely removed, or the residual lesion is only carcinoma in situ; for T1 stage lesions, postoperative pathological results must show the presence of bladder muscle tissue;\n7. ineligible or unwilling to undergo radical cystectomy;\n8. The level of organ function is good.\n9. use contraceptive measures (such as intrauterine device and contraceptive pill) during the study treatment period and within 3 months after the end of the study treatment period, and the female subject and the female partner of the male subject should use highly effective contraceptive methods; the female subject of childbearing age without surgical sterilization must be negative for serum HCG within 7 days before the first administration and must be non-lactating.\n\nExclusion Criteria:\n\n1. Received surgery or radiotherapy for bladder lesions within 2 weeks before the first administration;\n2. Those who have previously received the following treatments and have not experienced disease progression before enrolment t as assessed by the investigator:\n\n   * Intravesical instillation of cytotoxic chemotherapy or other drugs;\n   * Immune checkpoint inhibitor;\n   * Other investigational products for the treatment of NMIBC.\n3. Currently receiving study treatment in other clinical trials or less than 4 weeks from last participation to the first administration of this study;\n4. Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;\n5. Previous medical history or examination suggests active tuberculosis within 1 year prior to the first dose;\n6. Serious infection within 4 weeks before the first administration, or undefined fever\\>38.5 ℃ during screening\u002Fbefore the first administration;\n7. Obvious urinary tract infections and gross hematuria, indicating safety issues assessed by the investigators;\n8. Patients who discontinued treatment due to adverse reactions such as toxemia, systemic infection or urinary incontinence during previous BCG treatment;\n9. Using of immunosuppressive drugs within 2 weeks prior to the first administration, excluding nasal and inhaled corticosteroids, low physiological doses of systemic steroids, and prophylactic anti allergic steroids;\n10. Active or history of interstitial lung disease;\n11. History of clinically significant cardiovascular disease\n12. A history of immunodeficiency, including HIV seropositive, other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or those who are using immunosuppressants;\n13. With a history of active autoimmune disease；\n14. Patient with active hepatitis B (HBeAg positive and HBV DNA ≥ 500 IU\u002FmL), hepatitis C (HCV antibody positive and HCV RNA higher than the detection limit of the analytical method);\n15. Known allergic or intolerance to study drug, BCG (Phase Ib and Phase II subjects only) or excipients;\n16. The presence of other serious physical or mental illness, abnormal laboratory tests, and other factors that may increase the risk of participating in the study, or interfere with the results of the study; and any other conditions that the investigator deems inappropriate to participate in this study.",{"count":342,"type":21},150,[24,73],"The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG or SHR-1316 in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG or SHR-1316.\n\nTo evaluate the preliminary efficacy of SHR-1501 alone or in combination with BCG or SHR-1316 in the treatment of NMIBC.",[346],"High-risk NMIBC","2025-01-24",{"date":349,"type":32},"2025-01-28",{"date":351,"type":32},"2022-11-23",{"date":353,"type":21},"2027-05",{"name":37,"class":38},{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":374,"locationsCount":39},"100552544","phase-1-a-trial-of-shr-a2102-with-adebrelimab-with-or-without-other-antitumor-therapy-in-advanced-or-metastatic-esophageal-cancer-100552544","NCT06474468","A Trial of SHR-A2102 With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer","A Phase IB \u002FII, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With Adebrelimab With or Without Other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer","Inclusion Criteria:\n\n1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements；\n2. The age of signing the informed consent is 18 -70 years, regardless of gender；\n3. Provide archived or fresh tumor tissue for vendor test;\n4. At least one measurable lesion according to RECIST v1.1 criteria；\n5. Subjects with pathology confirmed locally advanced unresectable or metastatic esophageal squamous cell carcinoma;\n6. The ECOG score is 0 or 1；\n7. Expected survival ≥12 weeks\n8. Good level of organ function\n9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；\n2. Patients with uncontrolled tumor-related pain as determined by the investigator.\n3. Moderate or severe ascites with clinical symptoms (i.e., those who required therapeutic puncture or drainage within 2 weeks before the study treatment, and only those who showed a small amount of ascites without clinical symptoms could be included in the study); Unable to control or moderate or higher amounts of pleural effusion or pericardial effusion\n4. A history of gastrointestinal perforation and\u002For fistula within 6 months prior to initial medication, or significant tumor invasion of adjacent organs (large arteries or trachea, etc.), resulting in a higher risk of bleeding or fistula\n5. Have antitumor therapy was received 4 weeks before the start of the study；\n6. Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors\n7. Systemic antitumor therapy was received 4 weeks before the start of the study\n8. Treatment with CYP3A4, CYP2D6, P-gp, or BCRP booster or inducer is less than 5 drug half-lives from the date of first administration\n9. Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, diagnostic or superficial surgery was performed within 7 days prior to the initial study, or elective surgery was expected during the trial period;\n10. Perform non-chest radiation therapy with \\>30Gy within 28 days before dosing, chest radiation therapy with \\>30Gy within 24 weeks before first dosing, and radiation therapy with ≤30Gy within 14 days before first dosing\n11. Toxicity and\u002For complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria\n12. Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study treatment；\n13. Systemic immunosuppressive therapy was administered within 14 days prior to the first study\n14. Subjects with known or suspected interstitial pneumonia;\n15. In the first study, a single blood loss ≥50ml or a cumulative daily blood loss ≥300m occurred within 1 month before medication\n16. Subjects with severe cardiovascular and cerebrovascular disease;\n17. Arterial\u002Fvenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months prior to initial administration\n18. Had been diagnosed with any other malignancy\n19. Subjects who had a severe infection within 28 days prior to the first dose\n20. Active hepatitis B or active hepatitis C\n21. Patients with active pulmonary tuberculosis within 1 year prior to enrolment\n22. History of immune deficiency\n23. Severe allergic reactions are known to occur in individuals allergic to any component of SHR-A2102, SHR-1316, or other monoclonal antibody\u002Ffusion protein drugs\n24. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.",{"count":363,"type":21},148,[24,73],"The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Esophageal Cancer. To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Esophageal Cancer",[367],"Advanced or Metastatic Esophageal Cancer","2025-01-02",{"date":370,"type":32},"2025-01-03",{"date":372,"type":32},"2024-06-20",{"date":230,"type":21},{"name":37,"class":38},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":39},"100548173","phase-1-a-trial-of-shr-a2102-with-or-without-antitumor-therapy-in-advanced-solid-tumors-100548173","NCT06417554","A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors","A Phase IB \u002FII, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With or Without Antitumor Therapy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements；\n2. The age of signing the informed consent is above 18 years old, regardless of gender；\n3. The ECOG score is 0 or 1；\n4. Expected survival ≥12 weeks\n5. Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, stage Ib subjects who have failed standard treatment; Stage II subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors without systemic antitumor therapy；\n6. Provide archived or fresh tumor tissue；\n7. At least one measurable lesion according to RECIST v1.1 criteria；\n8. Good level of organ function；\n9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods\n\nExclusion Criteria:\n\n1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；\n2. Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors; Stage II was previously treated with PD-1\u002FPD-L1 inhibitors；\n3. Systemic antitumor therapy was received 4 weeks before the start of the study；\n4. Palliative radiotherapy was completed within 14 days before the first dose; Chest radiotherapy \\>30 Gy within 6 months prior to initial administration；\n5. Toxicity and\u002For complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria；\n6. Systemic immunosuppressive therapy was administered within 14 days prior to the first study；\n7. Subjects with known or suspected interstitial pneumonia；\n8. ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors；\n9. The presence of any active, known, or suspected autoimmune disease；\n10. Moderate or severe ascites with clinical symptoms, uncontrolled or moderate or above pleural effusion and pericardial effusion；\n11. The presence of clinical cardiac symptoms or diseases that are not well controlled；\n12. Any other malignancy diagnosed within the previous 5 years；\n13. Subjects who had a severe infection within 28 days prior to the first dose；\n14. Active hepatitis B or active hepatitis C；\n15. Patients with active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year prior but without formal treatment；\n16. History of immune deficiency；\n17. Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study period；\n18. Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter；\n19. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing; Presence of non-healing wounds or untreated fractures；\n20. Severe allergic reactions are known to occur in individuals allergic to any component of SHR-A2102, SHR-1316, or other monoclonal antibody\u002Ffusion protein drugs；\n21. Female subjects who are pregnant or plan to become pregnant during the study period；\n22. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention；\n23. In the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.",{"count":96,"type":21},[24,73],"The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with or without Antitumor Therapy in Advanced Solid Tumors. To explore the reasonable dosage of SHR-A2102 for Advanced Solid Tumors.",[76],"2024-12-29",{"date":388,"type":32},"2024-12-31",{"date":390,"type":32},"2024-05-13",{"date":392,"type":21},"2027-07",{"name":37,"class":38},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":401,"minAge":18,"maxAge":47,"enrollmentInfo":402,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":39},"100566381","phase-2-a-trial-of-shr-a2102-for-treatment-of-advanced-gynecological-malignancy-100566381","NCT06654440","A Trial of SHR-A2102 for Treatment of Advanced Gynecological Malignancy","An Open-label, Multicenter Phase II Clinical Study of SHR-A2102 for Injection in the Treatment of Advanced Gynaecological Malignancies","Inclusion Criteria:\n\n1. Participate in the study voluntarily, sign the informed consent form.\n2. Recurrent or metastatic gynecological malignancies that had failed standard treatments.\n3. At least one measurable lesion (RECIST version 1.1).\n4. ECOG 0\\~ 1.\n5. With adequate organ functions.\n6. Female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of SHR-A2102，Female participants' HCG must be negative within 72 hours prior to enrollment and must be non-lactating.\n\nExclusion Criteria\n\n1. With untreated brain metastasis or concomitant meningeal metastasis and spinal cord compression.\n2. Previous or contemporaneous malignancies, unless these malignancies reached complete remission at least 5 years prior before screening and did not require or are not expected to require other treatment during the study period. Such as Cutaneous squamous cell carcinoma, cervical carcinoma in situ etc.\n3. Had previously received antibody drug conjugates containing topoisomerase I inhibitors.\n4. Had undergone major surgery other than a diagnosis or biopsy within 28 days prior to the first administration; undergone minor traumatic surgery within 7 days prior to first administration.\n5. Known to be human immunodeficiency virus positive, active hepatitis B virus, or active hepatitis C virus.\n6. Had active pulmonary tuberculosis within 1 year prior to enrolment.\n7. Known to be allergic to any of the components of SHR-A2102.\n8. Were not fit to participate in this study by investigator's judgment.","FEMALE",{"count":199,"type":21},[73],"The main objective of this study is to evaluate the effectiveness and safety of SHR-A2102 for participants with advanced gynaecological cancer.",[406],"Advanced Gynecological Malignancy","2024-12-09",{"date":409,"type":32},"2024-12-10",{"date":411,"type":32},"2024-11-15",{"date":413,"type":21},"2026-10-31",{"name":37,"class":38},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":22,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":39},"100524420","phase-1-a-phase-i-clinical-study-of-shr-2005-intravesical-instillation-in-the-treatment-of-intermediate-and-high-risk-non-muscle-invasive-bladder-cancer-nmibc-100524420","NCT06108492","A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)","Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;\n2. ≥18 years of age, either sex;\n3. Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;\n4. ECOG performance status of 0-1;\n5. Life expectancy ≥ 2 years;\n6. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;\n2. Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;\n3. History of serious cardiovascular and cerebrovascular diseases;\n4. Severe infection within 2 weeks prior to the first dose;\n5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;\n6. Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;\n7. Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.",{"count":422,"type":21},170,[24],"This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.",[426],"Intermediate and High-risk Non-muscle Invasive Bladder Cancer","2024-11-28",{"date":429,"type":32},"2024-12-03",{"date":431,"type":32},"2023-11-28",{"date":433,"type":21},"2027-09-30",{"name":37,"class":38},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":301,"enrollmentInfo":442,"targetDuration":4,"studyType":22,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":447,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":39},"100570252","phase-2-a-phase-ii-study-of-shr-4602-as-montherapy-or-in-combination-with-other-anti-tumor-therapies-in-advanced-solid-tumors-100570252","NCT06704828","A Phase II Study of SHR-4602 as Montherapy or in Combination With Other Anti-tumor Therapies in Advanced Solid Tumors","An Open-label, Multi-center Phase II Study to Evaluate the Safety, Tolerablity, Pharmacokinetics, and Efficacy of SHR-4602 as Montherapy or in Combination With Other Anti-tumor Therapies in Sujbects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. 18-80 years old;\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n3. Stage I: subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, who have failed at least 1 line of standard treatment;\n4. Provide archived or fresh tumor tissue；HER2 expression is required for subjects in Stage I;\n5. At least one measurable lesion according to RECIST v1.1；\n6. Expected survival ≥12 weeks\n7. Good level of organ function；\n8. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose, be non-lactating. Male subjects whose partners are women of childbearing age and female subjects who are fertile must agree to avoid sperm or egg donation during the treatment period until 8 months after the last dose of the investigational drug;\n9. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements；\n\nExclusion Criteria:\n\n1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；\n2. Subjects with peripheral neuropathy；\n3. Have received anti-cancer treatment within 4 weeks prior the first dose of study treatment;\n4. Are participating in another clinical study or have received the last dose in a clinical study less than 4 weeks from the first dose;\n5. Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment;\n6. Have received treatment with strong CYP3A inducers or inhibitors, or P-gp inhibitors or inducers within 5 half-lives prior to the first dose;\n7. Toxicity and\u002For complications of previous antitumor therapy has not resolved to NCI-CTCAE level ≤1 or exclusion criteria；\n8. Have the following lung diseases or medical history: (1) known or suspected interstitial lung disease; (2) moderate to severe lung diseases that seriously affect lung function within the past 3 months; (3) any autoimmune, connective tissue, or inflammatory disease involving the lungs; (4) prior pneumonectomy; (5) Grade ≥ 3 interstitial lung disease during prior treatment with immune checkpoint inhibitors.\n9. Stage 2: ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors；\n10. Have any active, known or suspected autoimmune diseases;\n11. Moderate or severe ascites with clinical symptoms, uncontrolled or moderate or above pleural effusion and pericardial effusion；\n12. The presence of clinical cardiac symptoms or diseases that are not well controlled；\n13. Known hereditary or acquired hemorrhage and thrombophilia；\n14. Have untreated active hepatitis；\n15. Subjects who had a severe infection within 30 days prior to the first dose；\n16. Any other malignancy diagnosed within the previous 5 years；\n17. Patients with active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year prior but without formal treatment；\n18. History of immune deficiency；\n19. Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study period；\n20. Known severe allergic reactions to any component of SHR-4602, or other monoclonal antibody\u002Ffusion protein drugs；\n21. Female subjects who are pregnant or plan to become pregnant during the study period；\n22. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention；\n23. In the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.",{"count":443,"type":21},20,[73],"The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4602 as montherapy or in combination with other anti-tumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-4602 for advanced solid tumors.",[76],"NOT_YET_RECRUITING",{"date":449,"type":32},"2024-11-26",{"date":451,"type":21},"2024-12",{"date":453,"type":21},"2027-04",{"name":37,"class":38},{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":39},"100565220","phase-1-a-trial-of-shr-a2102-with-antitumor-therapy-in-advanced-urothelial-carcinoma-100565220","NCT06639347","A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma","An Open Label, Multicenter, Phase Ib\u002FIl Study to Evaluate the Safety, Tolerability, and Efficacy of SHR A2102 in Combination With Other Anti-cancer Agents in Patients With Advanced Urothelial Carcinoma","Inclusion Criteria:\n\n1. Competent to comprehend, sign, and date an informed consent form.\n2. Male or female subjects must be age 18 or older.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Subjects must have histologically documented, unresectable locally advanced or\n5. Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma.\n6. An archival tumor tissue sample or a fresh tissue sample should be provided.\n7. Subjects must have measurable disease according to RECIST (version 1.1).\n\nExclusion Criteria:\n\n1. Subjects with not adequately treated, or uncontrollable , or active CNS metastases.\n2. Subjects who have previously received TOPO1-based ADCs.\n3. Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.\n4. Subjects who have received radiotherapy within 14 days , or chest radiotherapy \\> 30Gy within 6 months prior to the first dose of study drug.\n5. Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1.\n6. Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment.\n7. Subjects who have known or suspected interstitial pneumonitis.\n8. Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs.\n9. Subjects who have any active, known or suspected autoimmune diseases.\n10. Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion.\n11. Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.",{"count":463,"type":21},90,[24,73],"The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.",[307],{"date":468,"type":32},"2024-11-18",{"date":470,"type":32},"2024-11-04",{"date":472,"type":21},"2027-05-31",{"name":37,"class":38},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":481,"targetDuration":4,"studyType":22,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":39},"100561408","phase-1-a-study-of-shr-a2102-in-combination-with-adebrelimab-and-shr-8068-in-subjects-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100561408","NCT06589778","A Study of SHR-A2102 in Combination With Adebrelimab and SHR-8068 in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Safety, Tolerability, and Efficacy of SHR-A2102 in Combination With Adebrelimab, With SHR-8068, in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Phase IB\u002FII Open-Label, Multicenter Clinical Study","Inclusion Criteria:\n\n1. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.\n2. Age 18\\~70 years old.\n3. Pathologically confirmed unresectable locally advanced\u002Fmetastatic non-small cell lung cancer.\n4. At least one measurable lesion per RECIST v1.1 criteria.\n5. ECOG PS score: 0-1.\n\nExclusion Criteria:\n\n1. Active or symptomatic brain metastases.\n2. Previous diagnosis of any other malignancy.\n3. Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion.\n4. Received anti-tumor therapy 4 weeks prior to initiation of study treatment.\n5. Uncontrolled tumor-related pain.\n6. Subjects with severe cardiovascular and cerebrovascular diseases.",{"count":482,"type":21},124,[24,73],"This study is a multicenter, open-label, dose-finding\u002Fefficacy-expanding Phase IB\u002FII clinical trial to evaluate SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer. The study consists of two phases: Phase IB to explore the safety\u002Ftolerability of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer; Phase II: To explore the efficacy of SHR-A2102 in combination with adebelimab in combination with SHR-8068 in patients with locally advanced or metastatic non-small cell lung cancer.",[486],"Non-Small Cell Lung Cancer","2024-11-07",{"date":489,"type":32},"2024-11-12",{"date":491,"type":32},"2024-09-27",{"date":493,"type":21},"2026-04-30",{"name":37,"class":38},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":39},"100562596","phase-1-a-trial-of-shr-7787-injection-in-patients-with-advanced-solid-tumors-100562596","NCT06605222","A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors","A Phase I\u002FII, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;\n2. Patients with unresectable recurrent or metastatic solid tumors;\n3. There is at least one lesion could be measured;\n4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n5. Adequate organ functions as defined;\n6. Life expectancy ≥3 months.\n\nExclusion Criteria:\n\n1. Patients with known active central nervous system (CNS) metastases;\n2. Subjects who had other malignancy in five years before the first dose;\n3. Patients with tumor-related pain that cannot be controlled as determined;\n4. Patients with serious cardiovascular and cerebrovascular diseases;\n5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;\n6. Patients with Severe infections;\n7. History of immunodeficiency;\n8. History of autoimmune diseases;\n9. Unresolved CTCAE Grade \\>1 toxicity attributed to any prior anti-tumor therapy\n10. Active infection;\n11. Pregnant or nursing women;\n12. Known history of serious allergic reactions to the investigational product or its main ingredients.",{"count":503,"type":21},201,[24,73],"The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.",[76],"2024-10-17",{"date":509,"type":32},"2024-10-18",{"date":511,"type":32},"2024-10-04",{"date":513,"type":21},"2026-11-30",{"name":37,"class":38},{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":85},"100549863","phase-1-phase-ibii-study-of-hrs2398-in-combination-with-adebrelimab-in-patients-with-advanced-solid-tumors-100549863","NCT06439589","Phase Ib\u002FII Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors","An Open-label, Multi-center Phase Ib\u002FII Study of HRS2398 in Combination With Adebrelimab in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.\n2. Age 18\\~75 years old.\n3. Dose escalation phase: patients with clinically diagnosed or pathologically confirmed advanced solid tumors who have failed standard therapy (disease progression during or after treatment) or for whom no effective standard treatment regimen exists.\n4. Dose Expansion and Efficacy Expansion Phase: Patients with advanced solid tumors who have received systemic immunotherapy and platinum-containing chemotherapy in the recurrent\u002Fmetastatic settings.\n5. At least one measurable lesion per RECIST v1.1 criteria.\n6. ECOG PS score: 0-1.\n\nExclusion Criteria:\n\n1. Patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy.\n2. Cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose.\n3. Presence of any active, known autoimmune disease.",{"count":523,"type":21},88,[24,73],"This study is a multicenter, open-label, dose-finding\u002Fefficacy-expanding phase Ib\u002FII clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of HRS2398 combined with Adebrelimab injection in patients with advanced solid tumors, determine the RP2D, and preliminarily evaluate the efficacy of HRS2398 combined with Adebrelimab in patients with advanced solid tumors.",[76],"2024-07-03",{"date":529,"type":32},"2024-07-05",{"date":531,"type":32},"2024-06-12",{"date":533,"type":21},"2025-12",{"name":37,"class":38},""]