[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Miracogen Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100591112","phase-3-a-study-of-mrg003-in-combination-with-pucotenlimab-versus-chemotherapy-in-the-treatment-of-patients-with-recurrent-or-metastatic-nasopharyngeal-carcinoma-100591112",false,"NCT06976190","A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma","A Randomized, Open-label, Multi-center, Phase III Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma","Magic-C002","Inclusion Criteria:\n\n* Willing to sign the informed consent form and follow the requirements specified in the protocol.\n* Life expectancy ≥ 12 weeks.\n* Patients with histologically and cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) who have failed at least one line of prior systemic therapy.\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 or 1.\n* No severe cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%.\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 hypersensitivity to any component of the investigational product.\n* Received systemic chemotherapy, targeted therapy, biological therapy or immunotherapy for anti-tumor purpose, or major surgery within 3 weeks prior to the first dose of study treatment.\n* Received anti-infection therapy within 2 weeks prior to the randomization\n* Prior treatment with MMAE\u002FMMAF ADC drugs\n* Central nervous system metastasis.\n* Poorly controlled systemic diseases\n* Patients with poorly controlled heart diseases\n* Poorly controlled pleural and peritoneal effusion or pericardial effusion\n* ≥Grade 2 toxic reaction or abnormal value of laboratory test caused by previous anti-tumor treatment\n* Patients with prior ≥Grade 3 immuno-related adverse events (irAEs)\n* Any clinically significant arteriovenous bleeding, pulmonary embolism, or deep venous thrombosis occurred within 3 months\n* Received allogeneic tissue\u002Fsolid organ transplantation.\n* Inoculate live vaccine within 30 days before the first dose.\n* Patients with a positive serum pregnancy test or who are breast-feeding or who do not agree to take adequate contraceptive measures during the treatment and for 180 days after the last dose of study treatment.\n* History of other primary malignant tumor diseases.\n* Other situations that are not suitable to participate a clinical trial per investigator's judgement","ALL","18 Years","75 Years",{"count":21,"type":22},446,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a randomized, open-label, multi-center, phase III study to evaluate the efficacy and safety, and immunogenicity of MRG003 in combination with pucotenlimab in patients with recurrent or metastatic nasopharyngeal carcinoma.",[28],"Recurrent or Metastatic Nasopharyngeal Carcinoma",[30,31,32],"MRG003","Pucotenlimab","Nasopharyngeal Carcinoma","RECRUITING","2026-01-16",{"date":36,"type":37},"2026-01-20","ACTUAL",{"date":39,"type":37},"2025-05-06",{"date":41,"type":22},"2030-12",{"name":43,"class":44},"Shanghai Miracogen Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100429137","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-mrg003-in-patients-with-recurrent-or-metastatic-squamous-cell-carcinoma-of-head-and-neck-100429137","NCT04868162","A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck","An Open-Label, Single Arm, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck.","Inclusion Criteria:\n\n* Willing to sign the ICF and follow the requirements specified in the protocol.\n* Expected survival time≥3 months.\n* Patients with histologically confirmed unresectable recurrent or metastatic squamous cell carcinoma of head and neck.\n* Failed prior platinum and\u002For anti-PD-1 treatment (Part A); failed or intolerant to at least one prior line of standard therapy (platinum-based regimen) (Part B)\n* Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* ECOG performance score 0 or 1.\n* Organ functions and coagulation function must meet the basic requirements.\n* Serum or urine pregnancy test negative within 7 days before the first dose of investigational drug.\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 4 or more systemic anti-tumor therapies for the recurrent or metastatic squamous cell carcinoma of head and neck.\n* ≥Grade 2 peripheral neuropathy\n* Prior anti-tumor therapy with MMAE\u002FMMAF ADCs\n* BMI≤17\n* Expected surgery or any other form of systemic or local anti-tumor therapy.\n* History of systemic chemotherapy within 3 weeks before the first administration of the investigational drug, targeted small molecule therapy within 2 weeks or 5 half-life periods before the first administration (whichever is shorter), antitumor biological therapy or immunotherapy within 4 weeks before the first administration, or major surgery.\n* Known active CNS metastasis and\u002For cancerous meningitis.\n* Residual toxicity reactions caused by previous anti-tumor treatment or abnormal values of laboratory tests higher than grade 1 (CTCAE v5.0). Prior Grade 3 to 4 immune-related AE (irAE) or ≥Grade 2 heart-related irAE.\n* Uncontrolled or poorly controlled heart disease.\n* History of pulmonary embolism or deep vein thrombosis within 3 months before the first administration of the investigational drug.\n* Known history of malignancy.\n* History of severe dermatosis.\n* Uncontrolled or poorly controlled hypertension.\n* Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy.\n* Known allergic reaction to any ingredients or excipients of investigational drugs.\n* Known active hepatitis B or C.\n* Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue\u002Forgan transplantation, stem cell or bone marrow transplantation, or solid organ transplantation.\n* Active bacterial, viral, fungal, rickettsia, or parasitic infections that require systemic anti-infective treatment.\n* Vaccination of live virus vaccine within 30 days before the first administration of the study drug. Inactivated seasonal influenza vaccine or approved COVID-19 vaccine is allowed.\n* History of previous or concurrent interstitial pneumonia, radiation pneumonitis, severe chronic obstructive pulmonary disease, severe pulmonary dysfunction, symptomatic bronchospasm, etc.\n* Patients receiving immunology-based treatment for any reason.\n* Uncontrolled pleural effusion, pericardial effusion or recurrent ascites.\n* Potent CYP3A4 inhibitors or inducers are in use and cannot be discontinued.\n* Women who are lactating or pregnant.\n* Other conditions that in the clinical judgement of the investigator make the patient not suitable for participation in this study.",{"count":54,"type":22},116,[56],"PHASE2","The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and neck.",[59],"Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck",[30,61,62,63,64],"Squamous Cell Carcinoma of Head and Neck","EGFR","HX008","PD-1","2025-07-02",{"date":67,"type":37},"2025-07-08",{"date":69,"type":37},"2021-04-23",{"date":71,"type":22},"2026-12",{"name":43,"class":44},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":45},"100497254","phase-3-a-study-of-mrg002-versus-investigators-choice-of-chemotherapy-in-the-treatment-of-patients-with-her2-positive-unresectable-advanced-or-metastatic-urothelial-cancer-100497254","NCT05754853","A Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Advanced or Metastatic Urothelial Cancer","An Open-label, Randomized, Multi-center, Phase III Clinical Study of MRG002 Versus Investigator's Choice of Chemotherapy in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Urothelial Cancer Previously Treated With Platinum-based Chemotherapy and PD-1\u002FPD-L1 Inhibitors","Inclusion Criteria:\n\n* 1\\. Willing to sign the ICF and follow the requirements specified in the protocol.\n\n  2\\. Aged 18 to 75 (including 18 and 75), both genders. 3. Expected survival time ≥ 12 weeks. 4. Patients with unresectable locally advanced or metastatic urothelium cancer confirmed by histopathology.\n\n  5\\. Patients who have failed prior platinum-based chemotherapy and PD-1\u002FPD-L1 inhibitors and have have progressive disease or recurrence on or after their most recent therapy.\n\n  6\\. Archival or biopsy tumor specimens should be provided (primary or metastatic).\n\n  7\\. HER2 positive (IHC 3+ or IHC 2+) in the tumor specimens confirmed by central laboratory test.\n\n  8\\. Patients must have measurable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n\n  9\\. ECOG performance score 0 or 1. 10. Prior anti-tumor treatment-related AEs (NCI-CTCAE v5.0 Criteria) have recovered to ≤ Grade 1 (except alopecia, Grade 2 hypothyroidism, non-clinically significant or asymptomatic laboratory abnormalities).\n\n  11\\. Organ function must meet the basic requirements. 12. Patients of childbearing potential must take effective contraceptive measures during the treatment and for 180 days after the last dose of treatment.\n\nExclusion Criteria:\n\n* 1\\. History of hypersensitivity to any component of MRG002 or history of hypersensitivity of ≥ Grade 3 to trastuzumab.\n\n  2\\. Patients who have received ADC drugs, or prior taxane, gemcitabine, and pemetrexed for locally advanced or metastatic urothelial cancer; or have received investigational drugs from other clinical trials, chemotherapy, radiotherapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose; or have received Chinese medicine (herbal medicine) or Chinese patent medicine with anti-tumor indications within 2 weeks prior to the first dose; or have received strong CYP3A4 inhibitors within 2 weeks prior to the first dose or have current requirement of CYP3A4 inhibitors; or had major surgery within 4 weeks prior to the first dose without full recovery or planned surgery within 12 weeks after study treatment.\n\n  3\\. Patients with clinical symptoms such as plural, abdominal or pericardial effusion requiring puncture drainage.\n\n  4\\. Patients with central nervous system (CNS) metastasis and\u002For neoplastic meningitis.\n\n  5\\. Any severe or uncontrolled systemic diseases. 6. Patients with poorly controlled heart diseases. 7. Evidence of active infections, including but not limited to Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection.\n\n  8\\. History of other primary malignancies. 9. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.\n\n  10\\. Peripheral neuropathy greater than Grade 1. 11. History of cirrhosis. 12. Patients with active autoimmune disease or a history of autoimmune disease, who are using immunosuppressive agents, or systemic hormone therapy and still receiving them within 2 weeks prior to enrollment.\n\n  13\\. Uncontrolled tumor-associated bone pain or urgent spinal cord compression. Patients requiring pain control must have been on a stable treatment regimen for at least 2 weeks at the time of first dose 14. Other conditions inappropriate for participation in this clinical trial, at the discretion of the investigator.",{"count":81,"type":22},290,[25],"The primary objective of this study is to compare the overall survival (OS) and progression-free survival (PFS) between MRG002 and investigator selected chemotherapy in patients with HER2-positive unresectable locally advanced or metastatic urothelial cancer previously treated with platinum-based chemotherapy and PD-1\u002FPD-L1 inhibitors.",[85],"Advanced or Metastatic Urothelium Cancer",[87,88,89,90],"MRG002","Antibody Drug Conjugate (ADC)","HER2","Urothelium Cancer","2023-04-12",{"date":93,"type":37},"2023-04-13",{"date":95,"type":22},"2023-04-06",{"date":97,"type":22},"2027-01",{"name":43,"class":44},""]