[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lepu Biopharma Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":152},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,71,100,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100603617","phase-3-a-study-comparing-mrg004a-plus-best-supportive-care-versus-placebo-and-best-supportive-care-in-the-treatment-of-patients-with-advanced-pancreatic-cancer-100603617",false,"NCT07138846","A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer","A Randomized, Double-blind, Multi-center, Phase III Study of MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* Willing to sign the informed consent form and follow the requirements specified in the protocol.\n* Patients with histologically and cytologically confirmed locally advanced or metastatic pancreatic cancer, including adenocarcinoma, who have failed at least prior systemic therapies including gemcitabine and fluorouracil.\n* Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* The score of ECOG for performance status is 0 to 2.\n* Organ functions and coagulation function must meet the basic requirements.\n* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment.\n\nExclusion Criteria:\n\n* History of other primary malignant tumors\n* Active metastasis to brain or meninges\n* Active acute or chronic inflammatory skin disease, history of Steven-Johnson syndromes\n* History of active or chronic corneal and conjunctival diseases, or other clinically significant ocular diseases that affect the ophthalmic monitoring of the investigational drug\n* Received certain anti-tumor therapies or strong CYP3A4 inhibitors and have not complete the wash-out period, or have not fully recovered from major surgery\n* AEs due to prior anti-tumor therapy(ies) that have not resolved to ≤Grade 1 per CTCAE v5.0\n* Presence of ≥Grade 2 peripheral neuropathy per CTCAE v5.0\n* Poorly controlled pleural and peritoneal effusion or pericardial effusion\n* Severe cardiac dysfunction within 6 months before enrollment\n* History of ventricular tachycardia, or torsade des pointes\n* Uncontrolled or poorly controlled hypertension\n* Compression fractures of the spine that have not been treated with surgery and\u002For radiation therapy, or have not been stable within 2 weeks before randomization\n* Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.\n* Patients with high risk of bleeding per investigator's judgement.\n* Patients who have active infection including but not limited to hepatitis B, hepatitis C, AIDS, or syphilis.\n* Active uncontrolled bacterial, viral, fungal, rickettsial, or parasitic infection.\n* Moderate to severe dyspnea at rest, severe primary lung disease, interstitial lung disease, or pneumonia.\n* Uncontrolled pain due to cancer\n* Active or history of autoimmune disease that requiring systemic hormone therapy\n* History of hypersensitivity to any component of the investigational product.\n* Other situations that are not suitable to participate a clinical trial per investigator's judgement","ALL","18 Years",{"count":19,"type":20},231,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, double-blind, multi-center, phase III study to evaluate the efficacy and safety, pharmacokinetic profile and immunogenicity of MRG004A in patients with advanced pancreatic cancer.",[26],"Advanced Pancreatic Cancer",[28,29,30,31],"MRG004A","Best Supportive Care","Placebo Controlled","Pancreatic Cancer","NOT_YET_RECRUITING","2026-05-12",{"date":35,"type":36},"2026-05-15","ACTUAL",{"date":38,"type":20},"2027-01",{"date":40,"type":20},"2027-06",{"name":42,"class":43},"Lepu Biopharma Co., Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100638040","phase-2-pucotenlimab-plus-becotatug-vedotin-in-perioperative-treatment-of-locally-advanced-resectable-head-and-neck-squamous-cell-carcinoma-100638040","NCT07586124","Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma","A Multicenter, Randomized, Double-Blind, Phase II Clinical Study of Pucotenlimab Injection Combined With Becotatug Vedotin for Injection as Perioperative Therapy in Participants With Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Life expectancy ≥ 6 months.\n2. Subjects with histologically confirmed, resectable Stage III-IVA head and neck squamous cell carcinoma (HNSCC) eligible for curative-intent surgery.\n3. At least one extracranial measurable lesion per RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n5. No severe cardiac dysfunction.\n6. Must provide tumor tissue sample not previously subjected to radiotherapy.\n7. Adequate organ function.\n8. Subjects of childbearing potential must use effective contraception during the study and for 180 days after the last dose.\n\nExclusion Criteria:\n\n1. Primary tumor originating from nasopharynx, nasal cavity, paranasal sinuses, salivary gland, thyroid\u002Fparathyroid gland, skin, or unknown primary site (squamous cell carcinoma).\n2. Head and neck cancer deemed non-resectable by the investigator.\n3. Prior treatment with anti-PD-1, anti-PD-L1, MMAE\u002FMMAF-based ADC agents, or other T-cell immune checkpoint inhibitors.\n4. Prior radiotherapy, systemic anti-tumor therapy, or other investigational therapy for head and neck cancer before study entry.\n5. Major surgery within 4 weeks before study entry, or not fully recovered from surgical toxicities\u002Fcomplications. Minor procedures (e.g., vascular access placement, percutaneous\u002Fendoscopic head\u002Fneck biopsy, tracheostomy tube exchange) are allowed.\n6. Grade ≥2 peripheral neuropathy (CTCAE v5.0).\n7. Active autoimmune disease requiring systemic treatment within 2 years before first dose.\n8. Receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 2 weeks before first dose.\n9. Radiologically detectable central nervous system metastases and\u002For carcinomatous meningitis.\n10. Uncontrolled pleural, peritoneal, pelvic effusion, or pericardial effusion.\n11. Any severe or uncontrolled systemic disease.\n12. Prior or planned allogeneic tissue\u002Fsolid organ transplantation.\n13. Known hypersensitivity to any active ingredient or excipient of the study drugs.\n14. Evidence of active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).\n15. Anti-infective therapy within 2 weeks before randomization.\n16. Stroke or transient ischemic attack within 6 months before enrollment.\n17. Uncontrolled or poorly controlled cardiac disease.\n18. Deep or intraluminal bleeding requiring interventional\u002Fsurgical hemostasis or blood transfusion within 3 months, or current history of coagulopathy.\n19. Pulmonary embolism or deep vein thrombosis within 3 months.\n20. History of or current interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, bronchospasm, etc.\n21. Received live vaccine within 30 days before first study dose.\n22. History of other primary malignancy.\n23. Positive serum pregnancy test or breastfeeding female.\n24. Contraindications to study drugs (pucotenlimab and\u002For becotatug vedotin) or their excipients; severe hypersensitivity (Grade ≥3) to radiotherapy, cisplatin or its analogues.\n25. Any condition that the investigator considers unsuitable for participation in the trial.\n26. Grade ≥2 hearing impairment per CTCAE v6.0.",{"count":53,"type":20},80,[55],"PHASE2","A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally advanced resectable head and neck squamous cell carcinoma",[58],"Head and Neck Squamous Cell Carcinoma",[60,61],"Pucotenlimab","Becotatug Vedotin","2026-05-07",{"date":64,"type":36},"2026-05-14",{"date":66,"type":20},"2026-05",{"date":68,"type":20},"2028-12",{"name":42,"class":43},15,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100614764","phase-2-study-of-cretostimogene-given-in-patients-with-non-muscle-invasive-bladder-cancer-unresponsive-to-bacillus-calmette-guerin-100614764","NCT07283835","Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin","A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer","Inclusion Criteria:\n\nIn order to be eligible for participation in this trial, the patient must:\n\n1. Be ≥18 years of age on day of signing informed consent.\n\n   \\- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta\u002FT1 papillary disease.\n2. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n3. Have all Ta and\u002For T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.\n4. Demonstrate adequate organ function.\n5. Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta\u002FT1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.\n6. Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.\n\nExclusion Criteria:\n\n1. Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3\u002FT4, any N) or metastatic bladder cancer.\n2. History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.\n3. Has received systemic anti-cancer therapy, including investigational agents.\n4. Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.\n5. Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.\n6. Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.",{"count":79,"type":20},16,[55],"This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta\u002FT1 papillary tumors.",[83,84],"Non Muscle Invasive Bladder Cancer","High-grade Ta\u002F T1 Papillary Disease Bladder Cancer",[86,87,88,89],"high-grade Ta papillary disease","high-grade T1 papillary disease","carcinoma in situ","Bacillus-Calmette-Guerin unresponsive","RECRUITING","2026-04-22",{"date":93,"type":36},"2026-04-23",{"date":95,"type":36},"2025-12-04",{"date":97,"type":20},"2028-12-31",{"name":42,"class":43},14,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100629808","phase-1-mrg006a-combination-therapy-for-advanced-hepatocellular-carcinoma-phase-iii-100629808","NCT07479485","MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I\u002FII)","An Open-Label, Multicenter, Phase I\u002FII Study Evaluating MRG006A in Combination With Immune Checkpoint Inhibitors and Targeted Therapy in Patients With Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Able to understand and provide written informed consent, and comply with the requirements specified in the protocol.\n2. Life expectancy ≥ 3 months.\n3. Must provide tumor tissue specimens for GPC3 testing.\n4. Histologically\u002Fcytologically confirmed hepatocellular carcinoma (HCC), Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B not amenable to curative surgery and\u002For locoregional therapy.\n5. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and modified RECIST (mRECIST).\n6. No prior systemic antineoplastic therapy for unresectable HCC before first dose administration.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with no deterioration within 2 weeks prior to first study drug administration.\n8. Adequate organ function as specified.\n9. Negative serum pregnancy test within 7 days prior to first dose (women of childbearing potential). Pregnant or lactating women are not eligible for this study.\n10. Women of childbearing potential and male patients must agree to use adequate contraception during MRG006A treatment and for 180 days after the last infusion.\n\nExclusion Criteria:\n\n1. Prior histologically\u002Fcytologically confirmed diagnosis of hepatocellular carcinoma with fibrolamellar, sarcomatoid, cholangiocarcinoma, or other components.\n2. History of hepatic failure or hepatic encephalopathy, or history of liver transplantation.\n3. Pleural effusion, ascites, or pelvic effusion, or clinically significant pericardial effusion.\n4. Acute or chronic active hepatitis B or hepatitis C infection.\n5. Central nervous system metastases.\n6. Prior locoregional therapy for hepatocellular carcinoma within 4 weeks before first dose administration.\n7. Receipt of live attenuated vaccines within 4 weeks before first dose or planned administration during the study period.\n8. Major surgical procedure within 4 weeks before first dose, or the presence of unhealed wounds, ulcers, or bone fractures.\n9. Uncontrolled or poorly controlled medical conditions.\n10. Toxicities from prior therapy that have not resolved to Grade 0 or 1 before first dose of study treatment.\n11. Severe cardiac insufficiency or cerebrovascular events within 6 months prior, or occurrence of pulmonary embolism, deep vein thrombosis, gastrointestinal perforation and\u002For fistula, or intestinal obstruction.\n12. Patients with double or multiple primary malignancies.\n13. Hypersensitivity to any component or excipient of the investigational product.\n14. Active or poorly controlled severe infection.\n15. Any severe and\u002For uncontrolled systemic disease that, in the opinion of the investigator and sponsor, renders the patient unsuitable for participation in this study.",{"count":108,"type":20},160,[110,55],"PHASE1","This is an open-label, multicenter, Phase I\u002FII clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MRG006A in combination with immune checkpoint inhibitors and targeted therapy in patients with advanced hepatocellular carcinoma (HCC).",[113],"Hepatocellular Carcinoma",[115,60,116,117],"MRG006A","Bevacizumab","TKI","2026-03-15",{"date":120,"type":36},"2026-03-18",{"date":122,"type":20},"2026-04",{"date":124,"type":20},"2029-04",{"name":42,"class":43},8,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":150,"locationsCount":151},"100600167","phase-1-a-study-of-mrg006a-in-the-treatment-of-patients-with-advanced-solid-tumors-100600167","NCT07093970","A Study of MRG006A in the Treatment of Patients With Advanced Solid Tumors","A Phase I\u002FII, Open-label, Multi-center, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of MRG006A in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Understand and provide written informed consent and comply with the requirements set forth in the protocol.\n2. age ≥ 18 years, ≤ 75 years.\n3. Expected survival ≥ 3 months.\n4. For patients with stage I and II disease, tumor tissue samples for GPC3 and P53 testing must be provided.\n5. Patients with histologically or cytologically confirmed advanced solid tumors.\n6. At least one measurable lesion according to RECISTv1.1 and mRECIST (HCC patients).\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Organ function must meet basic requirements.\n9. Women who are pregnant or breastfeeding are not included in this study.\n10. Female and male patients of childbearing potential must agree to take adequate measures.\n\nExclusion Criteria:\n\n1. Moderate and above thoracoabdominal pelvic fluid and pericardial effusion with clinical symptoms.\n2. History of liver failure and hepatic encephalopathy.\n3. Portal vein tumor thrombus involving both the main portal vein and left and right branches, or involving both the main portal vein and mesenteric vein needs to be excluded. The tumor involves the vena cava, or has formed a vena cava tumor thrombus.\n4. Residual toxicity due to previous anti-tumor therapy or clinically significant laboratory abnormalities higher than grade 1 (CTCAEv5.0).\n5. For liver cancer, previous or current central nervous system metastases and\u002For meningeal metastases. Patients with treated stable brain metastases from non-hepatic cancers may participate.\n6. Patients at high risk of bleeding.\n7. Severe cardiac insufficiency within 6 months prior to enrollment.\n8. Pulmonary embolism or deep venous thrombosis within 3 months before the first study drug treatment;\n9. History of gastrointestinal perforation, fistula, and bowel obstruction, extensive bowel resection, Crohn 's disease, ulcerative colitis, or chronic diarrhea for the past 6 months.\n10. Patients with double cancer and multiple cancer.\n11. Uncontrolled or poorly controlled disease.\n12. History of ventricular tachycardia or torsades de pointes.\n13. Previous or combined interstitial pneumonia, severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm and other medical history;\n14. Allergic reactions to any component or excipient of MRG006A, or known Grade ≥ 3 allergic reactions to other prior anti-GPC3 or other monoclonal antibodies.\n15. Acute or chronic active hepatitis B or C infection.\n16. Active or clinically poorly controlled serious infection.\n17. Receiving anti-tuberculosis treatment or receiving anti-tuberculosis treatment within 1 year before the first dose.\n18. People infected with human immunodeficiency virus (HIV), known syphilis infection requiring treatment.\n19. Use of systemic corticosteroids within 4 weeks prior to first treatment.\n20. Use of strong CYP3A4 inducers, strong CYP3A4 inhibitors within 14 days or 5 times the half-life prior to the first dose.","17 Years","85 Years",{"count":137,"type":20},343,[110,55],"The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG006A in patients with advanced solid tumors.",[141],"Advanced Solid Tumors",[115,143,141],"Antibody Drug Conjugate (ADC)","2026-01-20",{"date":146,"type":36},"2026-01-22",{"date":148,"type":36},"2024-07-24",{"date":68,"type":20},{"name":42,"class":43},2,""]