[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mabwell (Shanghai) Bioscience Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":460},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,40,62,87,112,136,154,175,197,218,238,259,280,306,334,356,376,405,424,442],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100637371","phase-2-a-phase-ii-study-of-9mw3811-in-patients-with-pathological-scar-100637371",false,"NCT07576608","A Phase II Study of 9MW3811 in Patients With Pathological Scar","A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics Properties, and Preliminary Efficacy of 9MW3811 in Patients With Pathological Scar","Inclusion Criteria:\n\n* Age ≥18 years\n* Pathological scar with no spontaneous regression over the prior 6 months\n* At least one scar with modified Vancouver Scar Scale (mVSS) score ≥9\n* Willing to use effective contraception for 6 months after last dose (if of childbearing potential)\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Contracture scar causing deformity\n* All eligible scars either \\>10 cm in length and \\>5 cm in width, or located exclusively on sun-exposed areas (head, face, hands)\n* Evidence of scar infection or active systemic infection requiring treatment\n* Use of anti-scar medications (e.g., corticosteroids, immunosuppressants) or anti-scar procedures (surgery, laser, radiation, etc.) within 4 weeks prior to first dose\n* Prior treatment with IL-11 cytokine or IL-6 family targeted therapy (e.g., tocilizumab) within specified washout periods\n* Participation in another interventional study within 28 days\n* Positive serology for HBV, HCV, HIV, or syphilis with clinical significance\n* History of severe allergy or known hypersensitivity to study drug components\n* Clinically significant laboratory abnormalities (eGFR \\\u003C90 mL\u002Fmin\u002F1.73m², PLT \\\u003C100×10⁹\u002FL, QTc \\>450\u002F470 ms, bilirubin \\>1.5×ULN, AST\u002FALT \\>1.5×ULN)\n* Alcohol or drug abuse within 1 year\n* Pregnancy, breastfeeding, or unwillingness to use contraception\n* Any other condition that, in the investigator's judgment, would compromise subject safety or study compliance","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of 9MW3811 in patients with pathological scar.",[26],"Scar","RECRUITING","2026-04-30",{"date":30,"type":31},"2026-05-08","ACTUAL",{"date":33,"type":31},"2025-12-29",{"date":35,"type":20},"2026-12",{"name":37,"class":38},"Mabwell (Shanghai) Bioscience Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100609590","phase-1-first-in-human-study-of-7mw4911-in-gi-cancer-100609590","NCT07216560","First-in-human Study of 7MW4911 in GI Cancer","A Phase I\u002FII Study of 7MW4911 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With Advanced Colorectal Cancer and Other Advanced Gastrointestinal Tumors","Inclusion Criteria:\n\n1. Aged 18 and above\n2. ECOG 0-1\n3. Life expectancy ≥ 3 months\n4. Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.\n5. Disease progression after the most recent treatment regimen\n6. At least one measurable lesion according to RECIST v1.1\n7. Provision of archival tumor tissue or fresh biopsy.\n8. Adequte hematologic funciton, liver function and renal function.\n9. Comply with contraceptive requirements\n\nExclusion Criteria:\n\n1. Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.\n2. Active, untreated or symptomatic CNS metastasis\n3. Effusions that require frequent drainage\n4. Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.\n5. Severe respiratory disease that required hospitalization in the last 28 days.\n6. Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration\n7. Poorly controlled blood glucose with fasting blood glucose above 10mmol\u002FL\n8. Recipient of allogeneic stem cell transplant or organ transplant\n9. Active HIV or hepatitis B\u002FC infection. Infection requiring systemic IV in the 14 days prior to study drug administration.\n10. Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.\n11. Prohibited treatment and treatment that requires washout period\n\n    1. Has received another Topo-I payload ADC, and\u002For another CDH17 targeting therapy.\n    2. Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration.\n    3. Major surgeries within 28 days prior to study drug administration\n    4. Investigational therapy within 28 days prior to study drug administration\n    5. Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed.\n    6. Use of strong CYP3A4 inhibitor or inducer\n12. Known hypersensitivity to 7MW4911 or components of the formulation\n13. Abuse of narcotic or psychoactive drugs\n14. Pregnant or breastfeeding women\n15. Other circumstances or conditions where the investigator judges to be unsuitable for study.",{"count":48,"type":20},200,[50,23],"PHASE1","This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.",[53],"GI Cancers","2026-04-29",{"date":28,"type":31},{"date":57,"type":31},"2026-01-13",{"date":59,"type":20},"2028-12",{"name":37,"class":38},5,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":39},"100635758","phase-3-a-study-of-9mw2821-versus-chemotherapy-in-participants-with-previously-treated-locally-advanced-or-metastatic-triple-negative-breast-cancer-100635758","NCT07556848","A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer","A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Have Previously Received Taxane-based Chemotherapy With or Without Immunotherapy and an Antibody-drug Conjugate With a Topoisomerase Inhibitor Payload","Inclusion Criteria:\n\n* Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n* Male or female subjects aged 18 to 75 years (including 18 and 75 years).\n* ECOG 0-1.\n* Histopathological diagnosed triple-negative breast cancer.\n* Patient has previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload.\n* Suitable for one of active comparator chemotherapy assessed by investigator.\n* An archival tumor tissue sample or a fresh tissue sample should be provided.\n* Life expectancy of ≥ 12 weeks.\n* Subjects must have measurable disease according to RECIST (version 1.1).\n* Adequate organ functions.\n* Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n\nExclusion Criteria:\n\n* Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions.\n* Preexisting peripheral neuropathy Grade ≥ 2.\n* Hemoglobin A1C (HbA1c) ≥ 8%.\n* Has ocular conditions or symptoms that may increase the risk of the study.\n* History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases and\u002For meningeal metastasis.\n* Previous medication does not meet the requirements.\n* Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n* Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases .\n* Active autoimmune disease.\n* History of another malignancy .\n* Pleural, abdominal, or pericardial effusion with clinical symptoms or that require drainage treatment.\n* Not suitable to receive study treatment for other conditions as per investigator.","75 Years",{"count":71,"type":20},356,[73],"PHASE3","The purpose of this study is to compare the efficacy and safety of 9MW2821 versus investigator's choice of chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload",[76],"Locally Advanced or Metastatic Triple-negative Breast Cancer",[78],"triple-negative breast cancer","NOT_YET_RECRUITING","2026-04-28",{"date":28,"type":31},{"date":83,"type":20},"2026-05",{"date":85,"type":20},"2028-09",{"name":37,"class":38},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100585942","phase-1-a-dose-randomization-study-of-bulumtatug-fuvedotin-in-tnbc-patients-previously-treated-with-adcs-100585942","NCT06908928","A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs","An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates","Inclusion Criteria\n\n* Patient has measurable disease by RECIST v1.1\n* Recurrent or metastatic triple-negative breast cancer patients as per current ASCO\u002FCAP guidelines\n* Patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload.\n* Patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.\n* Provision of archival tumor tissue or fresh tumor biopsy.\n* Capable of giving informed consent\n* Male or female subjects aged ≥ 18 years.\n* Subjects must be willing to receive blood transfusions if medically indicated.\n* ECOG 0-1\n* Adequate hematologic and organ function\n* Life expectancy of at least 3 months as assessed by the investigator\n* Compliance with contraceptive requirement\n\nExclusion Criteria:\n\n* Have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other MMAE based or nectin-4 targeted antibody-drug conjugates.\n* Unstable CNS metastasis requiring treatment in the last 28 days.\n* Acute infection requiring IV treatment in the last 14 days.\n* Grade ≥2 peripheral neuropathy.\n* Pregnant or breastfeeding women.\n* Life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk\n* Any systemic anticancer therapy in the last 28 days prior to first administration of study drug.\n* Active HCV, HBV or HIV infection unless well controlled with anti-viral therapy.\n* Active or chronic corneal disorder, keratitis, corneal ulcerations or Sjogren's syndrome.\n* Have any ongoing acute inflammatory skin disease or chronic skin disease not well controlled.\n* Have been diagnosed with another primary malignancy except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or subjects with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n* Have significant, uncontrolled or active cardiovascular disease\n* Have active or a history of pneumonitis or interstitial lung disease that requires corticosteroid treatment. Patients with radiation pneumonitis that does not require treatment is allowed.\n* Have uncontrolled diabetes.\n* Have received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.\n* Subjects known to be hypersensitive to bulumtatug fuvedotin or to any components of the formulation.\n* History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.\n* Have received a live vaccine within 30 days of planned start of study therapy.",{"count":95,"type":20},52,[50],"The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.",[99],"Triple Negative Breast Cancer",[101,102],"9MW2821","bulumtatug fuvedotin","2026-03-16",{"date":105,"type":31},"2026-03-17",{"date":107,"type":31},"2025-08-11",{"date":109,"type":20},"2028-05",{"name":37,"class":38},6,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":39},"100628785","phase-1-a-phase-ibii-study-of-7mw3711-combined-with-js207-in-advanced-solid-tumors-100628785","NCT07466160","A Phase Ib\u002FII Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors","A Multi-center, Open-label, Phase Ib\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Efficacy of 7MW3711 in Combination With JS207 With or Without Chemotheray in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n2. Life expectancy of at least 3 months as assessed by the Investigator.\n3. Phase 1b: Histologically or cytologically confirmed locally advanced or metastatic solid tumor, progressive after last treatment received and who progressed on or after standard therapies or intolerant to approved therapies or who lack of effient standard therapies. Phase 2: Histologically or cytologically confirmed locally advanced or metastatic selected advanced solid tumors.\n4. Measurable or evaluable disease by RECIST v1.1.\n5. Have adequate hematopoietic, renal and hepatic functions.\n6. Men or women willing to use adequate contraceptive measures throughout the study.\n\nExclusion Criteria:\n\n1. Have other prior malignancies within 3 years before the first administration.\n2. Known central nervous system metastatic disease or carcinomatous meningitis except for treated and stable brain metastases.\n3. Have significant, uncontrolled, or active cardiovascular disease.\n4. Known history of COPD, or intestinal lung disease, or other respiratory diseases requring inpatient treatments within 4 weeks prior to first administration.\n5. Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by NCI CTCAE V6.0.\n6. Have active infections requiring treatment within 14 weeks; have infection of HIV, active infection of HCV and HBV.\n7. Prior treatment with an antibody drug conjugate (ADC) that consists of an topoisomerase I inhibitor.\n8. Prior treatment with B7-H3 targeted agents.\n9. Have received any other investigational drugs or medical device within 4 weeks prior to the first administration.\n10. Pregnant, or nursing females.",{"count":120,"type":20},280,[50,23],"This study was designed to evaluate the efficacy and safety of 7MW3711 in combination with JS207 in subjects with solid tumor.",[124],"Solid Tumor",[126,127],"NSCLC","SCLC","2026-03-08",{"date":130,"type":31},"2026-03-12",{"date":132,"type":31},"2026-02-11",{"date":134,"type":20},"2029-12-31",{"name":37,"class":38},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":153,"locationsCount":39},"100613364","phase-1-first-in-human-study-of-7mw4911-in-patients-with-advanced-solid-tumors-100613364","NCT07265622","First-in-human Study of 7MW4911 in Patients With Advanced Solid Tumors","A Phase I\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of 7MW4911 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Aged 18\\~75.\n2. ECOG 0-1.\n3. Life expectancy ≥ 3 months.\n4. Participants with pathologically (histologically or cytologically) confirmed advanced solid tumors.\n5. Disease progression after the most recent treatment regimen.\n6. At least one measurable lesion according to RECIST v1.1.\n7. Provision of archival tumor tissue or fresh biopsy.\n8. Adequte hematologic funciton, liver function and renal function.\n9. Comply with contraceptive requirements.\n\nExclusion Criteria:\n\n1. Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.\n2. Active, untreated or symptomatic CNS metastasis.\n3. Effusions that require frequent drainage.\n4. Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.\n5. Severe respiratory disease that required hospitalization in the last 28 days.\n6. Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration.\n7. Poorly controlled blood glucose with fasting blood glucose above 10 mmol\u002FL.\n8. Recipient of allogeneic stem cell transplant or organ transplant\n9. Active HIV or hepatitis B\u002FC infection. Infection requiring systemic IV in the 14 days prior to study drug administration.\n10. Experiencing toxicities from prior anti-cancer therapies that have not recovered to CTCAE grade 0-1, except for alopecia and endocrinopathies.\n11. Prohibited treatment and treatment that requires washout period: (1) Has received another Topo-I payload ADC, and\u002For another CDH17 targeting therapy. (2) Received other cancer therapy within 5 half-lives or 21 days prior to study drug administration. (3) Major surgeries within 28 days prior to study drug administration. (4) Investigational therapy within 28 days prior to study drug administration. (5) Systemic treatment with immunosuppressive agents within 28 days prior to first drug administration. Physiological dose of glucocorticoid, topical glucocorticoid are allowed. (6) Use of strong CYP3A4 inhibitor or inducer.\n12. Known hypersensitivity to 7MW4911 or components of the formulation.\n13. Abuse of narcotic or psychoactive drugs.\n14. Pregnant or breastfeeding women.\n15. Other circumstances or conditions where the investigator judges to be unsuitable for study.",{"count":48,"type":20},[50,23],"This is the first-in-human study of 7MW4911 in Chinese patients, to investigate its prelimary safety and efficacy in patients with Advanced Solid Tumors.",[147],"Solid Tumors","2025-12-21",{"date":33,"type":31},{"date":151,"type":31},"2025-11-12",{"date":59,"type":20},{"name":37,"class":38},{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":39},"100617138","phase-2-9mw2821-combined-with-toripalimab-in-perioperative-patients-with-urothelial-cancer-100617138","NCT07314723","9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer","A Single Arm, Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial Cancer","Inclusion Criteria:\n\n* Sign the informed consent form approved by IEC.\n* Male or female subjects aged ≥18 years old.\n* ECOG status: 0 or 1.\n* Histologically confirmed urothelial cancer.\n* Imaging confirmed non-metastatic urothelial cancer (M0). Arm 1: MIBC, T2-4aN0-1. Arm 2: High-risk UTUC, N0. Arm 3: MIBC, T2-4aN0.\n* Adequate tumor tissues submitted for test.\n* Life expectancy for more than 12 weeks.\n* Adequate organ functions.\n* Proper contraception methods.\n* Willingness to follow the study procedures.\n\nExclusion Criteria:\n\n* Prior systemic anti-tumor therapy for urothelial cancer.\n* Previously treated with PD-1\u002FPD-L1 inhibitors or antibody-drug conjugates (ADCs).\n* History of another malignancy within 3 years.\n* History of autoimmune disease requiring systemic treatment within 2 years.\n* History of clinically significant cardiac\u002Fcerebrovascular diseases or thrombosis within 1 year.\n* Major surgery treated within 28 days; Cystoscopy\u002Fureteroscopy biopsy or intravesical instillation therapy within 7 days.\n* Peripheral neuropathy Grade ≥ 2.\n* Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.\n* Active HBV\u002FHCV\u002FHIV infection, etc.\n* Any other serious chronic or uncontrolled disease.\n* Any live vaccines got within 28 days.\n* Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.\n* Any potent CYP3A4 inducers\u002Finhibitors taken within 14 days.\n* Known allergic sensitivity to any of the ingredients of the study drug.\n* History of drug abuse or mental illness.\n* Other conditions unsuitable into the study.",{"count":162,"type":20},90,[23],"This is a single arm, open-label, multicenter phase II clinical study to evaluate the safety and efficacy of 9MW2821 combined with Toripalimab in perioperative patients with urothelial cancer.",[166],"Urothelial Carcinoma","2025-12-18",{"date":169,"type":31},"2026-01-02",{"date":171,"type":31},"2025-08-01",{"date":173,"type":20},"2028-12-31",{"name":37,"class":38},{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":182,"maxAge":69,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100615446","phase-2-a-study-to-evaluate-9mw1911-in-patients-with-chronic-obstructive-pulmonary-disease-copd-100615446","NCT07292714","A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)","A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate Efficacy and Safety of 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)","Inclusion Criteria:\n\n\\- 1.Male or Female patients must be 40 to 75 years of age inclusive； 2.Physician diagnosis of COPD for at least 1 year at screening； 3.Documented history of \\>= 2 moderate or \\>=1 severe COPD exacerbations within 12 months prior to screening.\n\n4.Moderate-to-severe COPD with post-BD FEV1\u002FFVC rato\\\u003C0.7 and a post-BD FEV1%predicted ≥20% and\\\u003C80% at screening； 5.Body Mass Index (BMI) of 16 kg\u002Fm² to 32 kg\u002Fm²； 6.Current tobacco smoker or former smoker with a history of smoking ≥ 10 pack-years 7.Participants with standard of care controller therapy, for ≥3 months prior to Screening and at a stable dose of controller therapy for at least 1 month prior to the screening；\n\nExclusion Criteria:\n\n* 1.Current diagnosis of asthma or documented history of asthma; 2.Diagnosis of Alpha-1 Antitrypsin Deficiency； 3.History of other clinically significant pulmonary diseases apart from COPD: such as sarcoidosis,interstitial lung diseases, bronchiectasis,cystic fibrosis，constrictive bronchiolitis,severe pulmonary hypertension or other active pulmonary diseases; 4.Long-term treatment with oxygen (oxygen therapy time \\>15h\u002Fday) or mechanical ventilation, or clinically significant apnea requiring continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV); 5.History of lung pneumonectomy, or lung volume reduction within 12 months prior to screening，or planned to undergo lung volume reduction surgery (LVRS) during the study period; 6.Patients in the acute phase of pulmonary rehabilitation(participating in, or scheduled for a pulmonary rehabilitation program within 4 weeks of screening); 7.Uncured upper or lower respiratory tract infections during the screening period; 8.Moderate to severe COPD exacerbations within 4 weeks prior to screening or during the screening period； 9.Any infection requiring hospitalization for ≥24 hours and\u002For treatment with oral, IV, or IM antibiotics within 4 weeks prior to screening or during the screening period; 10.Received treatment with oral, IV, or intramuscular (IM) corticosteroids (\\>10 mg\u002Fday prednisone or equivalent dose) within 4 weeks prior to starting study medication; 11.Myocardial infarction, unstable angina within 12 months prior to screening;or heart failure (NYHA Class III or IV) within 6 months prior to screening； 12.History of ventricular arrhythmias or risk factors for ventricular arrhythmias, such as structural heart disease (e.g., severe left ventricular systolic dysfunction, severe left ventricular hypertrophy ), family history of unexplained sudden death or long QT syndrome； 13. experienced transient ischemic attack or stroke within 6 months prior to screening; 14.with unstable cardiovascular diseases, such as pulmonary embolism or deep vein thrombosis that occurred within 6 months before screening, which the researchers believe may put the patient at risk or have a negative impact on the research results; 15.Known active tuberculosis or nontuberculous mycobacterial infection (subjects with positive interferon - γ release assay (IGRA) during the screening period, if evaluated as inactive tuberculosis by the researcher based on clinical manifestations and imaging examinations, etc., can participate in this study); 16.Positive for human immunodeficiency virus antibody (HIV-Ab), or positive for hepatitis B surface antigen (HBsAg) with HBV-DNA copies \\> 1000 IU\u002FmL or above the upper limit of normal (ULN) of the study center, or positive for hepatitis C virus antibody (HCV-Ab) with HCV-RNA copies above the ULN of the study center, or positive for Treponema pallidum antibody.\n\n  17.With active autoimmune disease or receiving immunosuppressive therapy for an autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis) are excluded.\n\n  18\\. with any active malignancy or a history of malignancy (except for low-grade tumors deemed cured ≥5 years before screening, such as cervical carcinoma in situ or basal cell carcinoma).\n\n  19.received a live attenuated vaccine within 4 weeks prior to screening or during the screening period.\n\n  20.received any biologic therapy (e.g., omalizumab, dupilumab, and\u002For anti-interleukin-5 therapy) within 3 months prior to screening ; 21.received any investigational therapy within 3 months prior to screening or within 5 drug-elimination half-lives, whichever is longer.\n\n  22.Any clinically significant ECG abnormality deemed by the investigator to potentially affect study conduct, such as QTc prolongation (QTcF \\> 450 ms for males, \\> 470 ms for females).\n\n  23.Alanine aminotransferase (ALT) \\>= 2 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) \\>= 2 times ULN; Total bilirubin \\>= 1.5 times ULN.\n\n  24.Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m2. 25.with any serious medical condition or clinically significant laboratory abnormality（in investigator's judgment） that could compromise the subject's safety or ability to participate in or complete the study.\n\n  26\\. With a history of alcohol abuse and\u002For substance abuse within 12 months prior to screening.\n\n  27.History of severe hypersensitivity or anaphylactic reactions to any biologic agent, or known hypersensitivity to any component of the investigational drug.\n\n  28\\. Pregnant or lactating women, Or female paticipants of child-bearing potential with a positive pregnancy test at screening.\n\n  29.Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.","40 Years",{"count":184,"type":20},360,[23],"The study is a Phase II, multicenter, double-blind, randomized, parallel, placebo-controlled clinical trial designed to evaluate the efficacy, safety of 9MW1911 in patients with Chronic Obstructive Pulmonary Disease (COPD).",[188],"Chronic Obstructive Pulmonary Disease COPD","2025-12-15",{"date":167,"type":31},{"date":192,"type":31},"2025-07-15",{"date":194,"type":20},"2028-02",{"name":37,"class":38},51,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":111},"100573935","phase-1-a-study-of-safety-tolerability-pharmacokinetics-pharmacodynamics-and-immunogenicity-of-9mw3011-in-patients-with-polycythemia-vera-100573935","NCT06752746","A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera","A Phase Ib, Multicenter, Randomized, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera","Inclusion Criteria:\n\n1. Male and female patients aged 18 years or older at the time of screening.\n2. A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria and are resistant to or intolerant of hydroxyurea or Interferon alpha.\n3. Have a treatment history for PV with resistance or intolerance to hydroxyurea or Interferon alpha.\n4. Subjects receiving hydroxyurea, Interferon alpha, or ruxolitinib must complete a washout period before administration of the investigational drug.\n5. Must agree to adhere to appropriate contraception requirements during the study period.\n6. All female subjects with fertility capacity tested negative for blood pregnancy.\n7. Voluntarily participate in clinical trials and agrees to participate in the study by giving written informed consent.\n\nExclusion Criteria:\n\n1. The spleen is palpable at least 5 centimeters below the left costal margin upon palpation at baseline.\n2. Heart failure, unstable angina pectoris, myocardial infarction, and other thrombotic diseases within the 6 months prior to screening.\n3. Abnormal QTc interval of electrocardiogram within the 6 months prior to screening.\n4. Uncontrolled hypertension prior to screening.\n5. Any non-PV myeloproliferative neoplasms (MPN).\n6. Blast cells and blast granulocytes in the peripheral blood within the 3 months prior to screening.\n7. Hematological indicators do not meet the requirements at the time of screening.\n8. Known positive for active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus (HIV) infection.\n9. History of invasive malignancies within the last 5 years.\n10. Severe infection or uncontrolled active infection.\n11. Other hematological and lymphatic system diseases or any diseases causing hemolysis or erythrocyte instability.\n12. Other systemic diseases or a family history of systemic diseases, may affect the subject's safety or any other diseases and physiological conditions that may affect the results of the study, judged by the investigator.\n13. Specific history of allergies.\n14. Subjects who have used monoclonal antibodies within the 6 months prior to screening.\n15. Patients who have received vaccinations within 6 weeks prior to screening.\n16. Subjects who have received other antitumor therapeutic drugs for PV prior to screening.\n17. Chronic diseases requiring treatment with systemic glucocorticoids or other immunosuppressants.\n18. History of drug abuse or illicit drug use within 3 months prior to screening.\n19. Participation in other clinical trials within 3 months prior to screening.\n20. Planned elective surgery during the study.\n21. History of surgery within 3 months prior to screening.\n22. Intolerable iron deficiency-related symptoms judged by the investigator prior to the first dosing.\n23. Pregnant or lactating females; women of reproductive age who are not using effective contraception.\n24. Individuals directly associated with the research and\u002For their immediate family members.\n25. Other factors which may potentially affect the assessment of the study results by the investigator.",{"count":205,"type":20},108,[50],"The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of 9MW3011 in Chinese patients with Polycythemia Vera（PV）.",[209],"Polycythemia Vera","2025-05-06",{"date":212,"type":31},"2025-05-11",{"date":214,"type":31},"2024-03-21",{"date":216,"type":20},"2026-06-30",{"name":37,"class":38},{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":39},"100588885","phase-1-a-clinical-study-of-9mw2821-monotherapy-or-combined-with-other-anticancer-therapy-in-advanced-solid-tumors-100588885","NCT06947226","A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors","A Phase Ib\u002Fll Clinical Study of Safety and Efficacy of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors","Inclusion Criteria:\n\n1. Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n2. Male or female subjects aged 18 to 75 years (including 18 and 75 years).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histopathological diagnosed of recurrent or locally advanced or metastatic solid tumors.\n5. Adequate tumor tissues submitted for test.\n6. Life expectancy of ≥ 12 weeks.\n7. Subjects must have measurable disease according to RECIST (version 1.1).\n8. Adequate organ functions.\n9. Sexually active fertile subjects, and their partners, must agree to use contraception during the study and at least 6 months after termination of study therapy.\n10. Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n1. History of another malignancy within 3 years before the first dose of study drug.\n2. Ongoing clinically significant toxicities related to prior treatment.\n3. Grade ≥ 2 peripheral neuropathy.\n4. Severe or uncontrolled gastrointestinal diseases.\n5. Other severe or uncontrolled diseases, including severe respiratory diseases, cardiovascular and cerebrovascular diseases of clinical significance.\n6. Experienced clinically significant bleeding or had a clear bleeding tendency.\n7. Central nervous system (CNS) metastasis and\u002For malignant meningitis.\n8. Clinically significant pleural, abdominal, or pericardial effusion.\n9. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug;\n10. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n11. Pregnant and lactating women.\n12. Other conditions that, in the Investigator's opinion, may not be suitable for the subject to be enrolled.",{"count":226,"type":20},188,[50,23],"This study is a Phase Ib\u002Fll, open-label, multicenter study designed to evaluate the safety and efficacy of 9MW2821 monotherapy or combined with other anticancer therapy in advanced solid tumors.",[147],"2025-04-21",{"date":232,"type":31},"2025-04-27",{"date":234,"type":20},"2025-04",{"date":236,"type":20},"2027-04",{"name":37,"class":38},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":245,"targetDuration":4,"studyType":21,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":39},"100531203","phase-3-a-study-to-evaluate-9mw2821-versus-chemotherapy-in-subjects-with-previously-treated-locally-advanced-or-metastatic-urothelial-cancer-100531203","NCT06196736","A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer","An Open-label, Randomized Phase 3 Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects With Locally Advanced or Metastatic Urothelial Cancer Who Have Previously Received PD-(L)1 Inhibitor and Platinum-containing Chemotherapy","Inclusion Criteria:\n\n1. Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n2. Male or female subjects aged 18 to 75 years (including 18 and 75 years).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histologically confirmed locally advanced or metastatic urothelial cancer, not amenable to resection with curative intent.\n5. Subject must have received a platinum containing chemotherapy and PD-(L)1 inhibitor in the metastatic\u002Flocally advanced setting. If platinum and\u002For PD-(L)1 inhibitor was administered in the adjuvant\u002Fneoadjuvant setting subject must have progressed during treatment or within 12 months of completion.\n6. Subject must have experienced radiographic progression during or after the last treatment regimen.\n7. An archival tumor tissue sample or a fresh tissue sample should be provided.\n8. Life expectancy of ≥ 12 weeks.\n9. Subjects must have measurable disease according to RECIST (version 1.1).\n10. Adequate organ functions.\n11. Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n12. Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n1. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC, received treatment of ADC with MMAE payload, received prior chemotherapy with all available study therapies in the control arm, any strong CYP3A4 inducers\u002Finhibitors within 14 days prior to the first dose of study drug.\n2. Preexisting treatment related toxicity Grade ≥ 2 (except alopecia and grade 2 endocrine system toxicity with stable replacement therapy).\n3. Major surgery within 28 days prior to first dose of study drug.\n4. Hemoglobin A1C (HbA1c) ≥ 8%.\n5. Preexisting peripheral neuropathy Grade ≥ 2.\n6. Any live vaccines within 28 days before first dose of study drug or during the study.\n7. Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.\n8. Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.\n9. Central nervous system metastases.\n10. History of another malignancy within 3 years before the first dose of study drug. Subjects with cured malignancies are allowed.\n11. History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.\n12. Has ocular conditions that may increase the risk of corneal epithelium damage.\n13. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n14. Uncontrolled tumor-related bone pain or spinal cord compression. Patients requiring pain medication must be on a stable regimen for at least 2 weeks before the first dose of study drug.\n15. Pleural effusion, ascites or pericardial effusion with syptoms or needed drainage.\n16. Condition or situation which may put the subject at significant risk.",{"count":246,"type":20},432,[73],"The purpose of this study was to compare the antitumor activity of 9MW2821 and chemotherapy in participants with locally advanced or metastatic urothelial cancer previously treated with PD-(L)1 inhibitor and platinum-containing chemotherapy.",[250],"Advanced Urothelial Carcinoma","2025-04-10",{"date":253,"type":31},"2025-04-13",{"date":255,"type":31},"2023-12-29",{"date":257,"type":20},"2027-07",{"name":37,"class":38},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":266,"minAge":17,"maxAge":69,"enrollmentInfo":267,"targetDuration":4,"studyType":21,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":277,"leadSponsor":279,"locationsCount":39},"100587331","phase-1-9mw2821-combined-with-other-antitumor-drugs-in-patients-with-advanced-gynecological-tumors-100587331","NCT06926998","9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors","An Open-Label, Multicenter Phase Ib\u002Fll Clinical Study Evaluating the Safety and Efficacy of 9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors","Inclusion Criteria:\n\n1. Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n2. Female subjects aged 18 to 75 years (including 18 and 75 years).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histopathological diagnosed of advanced gynecological tumors.\n5. Subjects must submit tumor tissues for test.\n6. Life expectancy of ≥ 12 weeks.\n7. Subjects must have measurable disease according to RECIST (version 1.1).\n8. Adequate organ functions.\n9. Sexually active fertile subjects must agree to use methods of contraception during the study and at least 180 days after termination of study therapy.\n10. Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n1. History of another malignancy within 3 years before the first dose of study drug.\n2. Patients with ongoing clinically significant toxicities related to prior treatment.\n3. Presence of Grade ≥ 2 peripheral neuropathy.\n4. Exclusion of prior diseases and prior treatments as specified in the protocol.\n5. Comorbidities: a. Hemoglobin A1C ≥ 8%; b. Ocular diseases or symptoms present prior to the first dose of study medication; c. Severe respiratory diseases; d. Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study medication; e. Active autoimmune diseases within 2 years prior to the first dose of study medication, or a history of autoimmune diseases with potential for recurrence; f. Active infections; g. Severe arterial or venous thromboembolic events.\n6. Clinically significant bleeding symptoms or a clear bleeding tendency within 3 months prior to the first dose of medication.\n7. Subjects with central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n8. Pleural, peritoneal, or pericardial effusion with clinical symptoms or requiring repeated drainage procedures.\n9. Prior Treatments: a. Major surgical procedures within 28 days prior to the first dose of study medication; b. Administration of other investigational drugs or experimental medical devices within 28 days prior to the first dose of study medication; c. Use of P-glycoprotein inhibitors or inducers, or potent CYP3A4 inhibitors within 14 days prior to the first dose of study medication; d. Receipt of live vaccines within 28 days prior to the first dose of study medication or planned administration of any live vaccine during the study period; e. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;.\n10. Subjects with a history of drug abuse or psychiatric disorders, or suspected allergy, intolerance, or severe infusion reactions to the investigational drug or any of its components.\n11. Pregnant or lactating women.\n12. Not suitable to receive study treatment for other conditions as per investigator.","FEMALE",{"count":268,"type":20},260,[50,23],"To evaluate the safety, tolerability, and preliminary efficacy of 9MW2821 in combination with other anti-tumor agents in patients with advanced gynecological malignancies.",[272],"Gynecological Malignancies","2025-04-08",{"date":275,"type":31},"2025-04-15",{"date":275,"type":20},{"date":278,"type":20},"2027-05-01",{"name":37,"class":38},{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":296,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},"100579371","phase-2-9mw2821--toripalimab-vs-9mw2821-for-1st-line-locally-advanced-or-metastatic-urothelial-carcinoma-100579371","NCT06823427","9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma","A Randomized Phase II Trial to Evaluate 9MW2821 in Combination With Toripalimab Compared With 9MW2821 Monotherapy for the 1st Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma","Inclusion Criteria:\n\n* Voluntary participation\n* Age 18-80\n* ECOG 0-1\n* Histologically confirmed inoperable locally advanced or metastatic urothelial carcinoma (including bladder, renal pelvis and ureter). Mixed histology with squamous or adenomatous differentiation is allowed if urothelial carcinoma differentiation is \\>50%.\n* Has not received any systemic treatment for locally advanced or metastatic urothelial carcinoma\n* At least 1 measurable target lesion that satisfies RECIST v1.1 definition. If the patient has received radiotherapy, the target lesion needs to be outside the radiation field or has demonstrated clear progression after radiotherapy.\n* Life expectancy over 12 weeks\n* Appropriate hematological and organ functions\n* Agree to contraceptive measures until 180 days after the last dose of study drug administration\n* Able to understand and follow study visits, treatment, laboratory assessment and other procedures\n\nExclusion Criteria:\n\n* Other concurrent malignancy within 3 years prior to randomization\n* Active autoimmune disease requiring systemic treatment within 2 years prior to randomization. Having received high dose corticosteroid (\\>10mg\u002Fday prednisolone equivalent) or other immunosuppressive agents.\n* Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 months prior to randomization\n* Major surgery within 28 days prior to randomization, except for minor procedures that the PI considers not to impact study participation. Live vaccine within 28 days prior to randomization or planning to take live vaccine during the study. Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Use of strong CYP3A4 inhibitors within 14 days prior to randomization.\n* Lung effusion or ascites that require treatment within 14 days prior to randomization. Cancer-related severe uncontrolled bone pain or spinal cord compression within 14 days prior to randomization. Active infection that requires systemic antibiotic treatment within 7 days prior to randomization.\n* Have received prior treatment with anti-PD-1, anti-PD-L1\u002FPD-L2 or anti-CTLA-4 therapies. Have received prior treatment with Nectin-4 targeted therapy or ADC with MMAE as payload. Have received allogeneic hematological stem cell transplantation or solid organ transplant.\n* Toxicities from previous cancer treatment (radiotherapy, chemotherapy or surgery) that have not recovered to grade 0-1 according to CTCAE v5.0, except for alopecia and skin hyperpigmentation.\n* Severe dry eyes, active keratitis, corneal ulceration or other risk factors for corneal diseases where the PI judges to be not suited for this study\n* Preexisting grade ≥ 2 neuropathy prior to randomization\n* Other uncontrolled serious illness\n* Brain metastasis or meningeal carcinomatosis\n* HBsAg positive, and HBV-DNA copy number positive ; HCV-Ab positive and HCV-RNA positive; HIV-Ab positive\n* Known allergy to the study drug or components of the study drug\n* Drug abuse or psychiatric disorder that would impact study compliance\n* Other circumstances that the PI judges to be not suitable for the study","80 Years",{"count":289,"type":20},60,[23],"This study will compare the efficacy of 9MW2821+toripalimab versus 9MW2821 monotherapy in locally advanced or metastatic urothelial carcinoma patients who have not received any systemic treatment in the metastatic or advanced setting.",[166,293,294,295],"Urothelial Carcinoma Bladder","Urothelial Carcinoma Recurrent","Urothelial Carcinoma of the Renal Pelvis and Ureter",[101],"2025-03-20",{"date":299,"type":31},"2025-03-21",{"date":301,"type":31},"2025-01-17",{"date":303,"type":20},"2027-06",{"name":37,"class":38},2,{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":266,"minAge":313,"maxAge":287,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":316,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":39},"100577922","phase-3-a-study-on-efficacy-safety-and-immunogenicity-of-9mw0311-in-postmenopausal-women-with-osteoporosis-100577922","NCT06804590","A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis","A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Clinical Efficacy, Safety, and Immunogenicity of Denosumab Injection 9MW0311 With Prolia® in Postmenopausal Women With Osteoporosis","Inclusion Criteria:\n\n* Women who can walk freely (≥50 and ≤80 years);\n* As measured by DXA, the absolute value of BMD at lumbar spine, femoral neck or total hip was -4.0\\\u003CT value ≤-2.5;\n* Subjects must have at least one of the following other risk factors: 1) history of previous fragility fractures; 2) Either or both parents have a history of hip fragility fracture; 3) Increased bone turnover rate during screening; 4) Low body weight; 5) Old age(≥70); 6) Currently smoking.\n* The duration of spontaneous amenorrhea was \\>2 years or \\>2 years after bilateral oophorectomy. If the status of bilateral oophorectomy is unknown or if the ovaries are preserved after hysterectomy, follicle stimulating hormone (FSH) levels \\>40mIU\u002FmL may be used to confirm the status of postoperative menopause.\n\nExclusion Criteria:\n\n* Bone\u002Fmetabolic disease\n* Hyperparathyroidism or hypoparathyroidism\n* Thyroid condition: Hyperthyroidism or hypothyroidism\n* Rheumatoid arthritis\n* Malignant tumors\n* Malabsorption syndrome\n* Liver cirrhosis, active hepatitis B or hepatitis C, and unstable liver disease; serum aspartate aminotransferase and alanine aminotransferase ≥ 2.0 times the upper limit of normal (ULN); alkaline phosphatase or total bilirubin ≥ 1.5 ULN;\n* Renal disease - severe impairment of kidney function\n* Clinically significant cardiovascular and cerebrovascular diseases (such as myocardial infarction, unstable angina or stroke, NYHA class III or IV heart failure in the 12 months prior to screening) and hematopoietic system disease judged by the investigator;\n* Hypercalcemia or hypocalcemia ;\n* vitamin D deficiency (25-hydroxyvitamin D, 25OHD \\\u003C20 ng\u002FmL);\n* Oral or dental diseases: previous or current evidence of mandibular osteomyelitis or osteonecrosis; Acute dental or mandibular disease requiring oral surgery; Planning invasive dental surgery; Failure to recover from dental or oral surgery;\n* Use of intravenous bisphosphonates within the previous 2 years;\n* oral bisphosphonates (used for at least 2 years, or used for less than 2 years but more than 3 months, with the last use occurring \\\u003C1 year before the screening);\n* Use of any of the following drugs within 6 weeks prior to screening that may affect bone metabolism:\n\n  1. parathyroid hormone (PTH) or PTH derivatives, such as teriparatide;\n  2. anabolic hormones or testosterone;\n  3. glucocorticoids (equivalent dose more than 5mg\u002F day of prednisone and continuous use for more than 10 days);\n  4. Selective estrogen receptor modulators (SERMs), such as raloxifene;\n  5. Menopausal hormone therapy (such as estrogen, estrogen + progesterone, tibolone);\n  6. Active vitamin D and its analogues (cumulative use of more than 30 days);\n  7. Other bone-active drugs include antiepileptic drugs (except benzodiazepines) and heparin;\n  8. Long-term systemic use of ketoconazole, adrenocorticotropin (ACTH), aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonists;\n  9. Chinese patent medicines for osteoporosis related treatment are clearly described in the instructions, such as Xianling Gubao capsule (tablet), Gushukang capsule (granule), Jintiange capsule and Qianggu capsule.\"\n* History of more than two vertebral fractures.","50 Years",{"count":315,"type":20},278,[73],"This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with osteoporosis at high risk for fracture.",[319],"Postmenopausal Women Osteoporosis",[321,322,323,324,325],"Denosumab","efficacy","MW031","postmenopausal women","safety","2025-01-27",{"date":328,"type":31},"2025-02-03",{"date":330,"type":31},"2024-11-16",{"date":332,"type":20},"2026-07-30",{"name":37,"class":38},{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":21,"phases":344,"briefSummary":345,"conditions":346,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":305},"100575475","phase-1-a-multiple-ascending-dose-study-of-9mw3011-in-patients-with-non-transfusion-dependent--thalassemia-100575475","NCT06772766","A Multiple Ascending Dose Study of 9MW3011 in Patients With Non-transfusion-dependent β-thalassemia","A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Non-transfusion-dependent β- Thalassemia","Key Inclusion Criteria:\n\n1. Male and female subjects aged 18 to 65 years (inclusive)\n2. Subject must have a documented genetic diagnosis of β-thalassemia or hemoglobin E\u002F β-thalassemia\n3. Subjects must meet the criteria for non-transfusion-dependent thalassemia\n4. Subjects must have a baseline hemoglobin level between 70-100 g\u002FL(inclusive), based on 2 consecutive measurements taken at least 1 week apart within 4 weeks before randomization\n5. Subjects must have evidence of iron overload during screening\n6. Subject must have performance status: Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1\n7. Subjects must fully understand the study procedures and methods, voluntarily participate in the trial, and sign an informed consent form\n\nKey Exclusion Criteria:\n\n1. Subjects diagnosed with alpha-thalassemia\n2. Subjects diagnosed with HbS\u002Fbeta-thalassemia or transfusion-dependent beta-thalassemia\n3. Subjects exhibit severe iron overload at the time of screening\n4. In addition to thalassemia, subjects have any other forms of anemia and hematological disorders that the investigator assesses may compromise safety or influence study outcomes\n5. Combined with any significant systemic diseases or psychiatric disorders\n6. Subjects have New York Heart Association (NYHA) Class III-IV heart failure and other cardiovascular diseases within 6 months prior to screening or currently present\n7. During the screening or baseline period, subjects exhibiting a QTcF interval of ≥450ms for males and ≥470ms for females on a 12-lead electrocardiogram (ECG), or presenting an abnormal 12-lead ECG with clinical significance\n8. Uncontrolled hypertension before screening\n9. A history of malignant neoplasm occurring within the last five years\n10. Severe infection requiring hospitalization or intravenous antimicrobial therapy, or uncontrolled systemic bacterial, fungal, or viral active infection\n11. Subject have received concomitant treatment that was not permitted by the protocol\n12. Subjects whose hematological parameters did not meet the inclusion criteria during screening\n13. Subjects with a history of substance abuse, as well as those who yield positive results on substance abuse screening\n14. Subjects who are unable to undergo MRI scans\n15. Pregnant or lactating women\n16. Subjects presenting any other factors deemed unsuitable for participation assessed by the investigator","65 Years",{"count":343,"type":20},40,[50],"This is a phase Ib, randomized, double-blind, placebo-controlled, multiple ascending dose study . The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics(PK), pharmacodynamics(PD), and immunogenicity of 9MW3011 in patients with non-transfusion-dependent β- thalassemia .",[347],"Beta-Thalassemia","2025-01-09",{"date":350,"type":31},"2025-01-14",{"date":352,"type":31},"2024-12-30",{"date":354,"type":20},"2026-10",{"name":37,"class":38},{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":69,"enrollmentInfo":363,"targetDuration":4,"studyType":21,"phases":365,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":39},"100553893","phase-2-a-clinical-study-of-9mw2821-and-pd-1-inhibitor-in-locally-advanced-or-metastatic-triple-negative-breast-cancer-100553893","NCT06492005","A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer","A Phase II Clinical Study of Efficacy and Safety of 9MW2821Monotherapy or Combined With PD-1 Inhibitor in Locally Advanced or Metastatic Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n2. Male or female subjects aged 18 to 75 years (including 18 and 75 years).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histopathological diagnosed of locally advanced or metastatic triple negative breast cancer. Not suitable for radical therapy.\n5. Subjects who have failed standard treatment or naive to systemic antitumor therapy in advanced setting.\n6. Subjects must submit tumor tissues for test.\n7. Life expectancy of ≥ 12 weeks.\n8. Subjects must have measurable disease according to RECIST (version 1.1).\n9. Adequate organ functions.\n10. Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n11. Subjects are willing to follow study procedures\n\nExclusion Criteria:\n\n1. Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions\n2. Preexisting peripheral neuropathy Grade ≥ 2.\n3. Hemoglobin A1C (HbA1c) ≥ 8%.\n4. Has ocular conditions that may increase the risk of corneal epithelium damage.\n5. History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases.\n6. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug (Cohort A). Received immune checkpoint inhibitor or systemic immunosuppressive therapy was administered within 14 days prior to the first study (Cohort B and C). traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC with MMAE payload, any P-glycoprotein (P-gp) inducers\u002Finhibitors or strong CYP3A4 inducers\u002Finhibitors within 14 days prior to the first dose of study drug, major surgery within 28 days prior to first dose of study drug or any live vaccines within 28 days before first dose of study drug or during the study..\n7. History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n8. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n9. Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug\n10. Active autoimmune disease requiring systemic treatment within 2 years before the subject's first study medication.\n11. History of another malignancy within 3 years before the first dose of study drug.\n12. Not suitable to receive study treatment for other conditions as per investigator.",{"count":364,"type":20},160,[23],"This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.",[368],"Triple-Negative Breast Cancer","2025-01-08",{"date":371,"type":31},"2025-01-10",{"date":373,"type":31},"2024-07-26",{"date":257,"type":20},{"name":37,"class":38},{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":266,"minAge":17,"maxAge":69,"enrollmentInfo":383,"targetDuration":4,"studyType":21,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":404,"locationsCount":305},"100569278","phase-3-a-study-to-evaluate-9mw2821-versus-treatment-of-physicians-choice-for-subjects-with-recurrent-or-metastatic-cervical-cancer-100569278","NCT06692166","A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer","A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 vs Treatment of Physician's Choice in Subjects With Recurrent or Metastatic Cervical Cancer Who Progressed on or After Platinum-based Chemotherapy","Inclusion Criteria:\n\n1. Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n2. Female subjects aged 18 to 75 years (including 18 and 75 years).\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent.\n5. Subject must have received a platinum-based chemotherapy with or without bevacizumab and received no more than 2 prior systemic therapy in the metastatic\u002Frecurrent setting. Subject must have experienced radiographic progression during or after the last treatment regimen.\n6. An archival tumor tissue sample or a fresh tissue sample should be provided.\n7. Life expectancy of ≥ 12 weeks.\n8. Subjects must have measurable disease according to RECIST (version 1.1).\n9. Adequate to receive one of the chemotherapy regimens in the control group (gemcitabine, pemetrexed, topotecan);\n10. Adequate organ functions.\n11. Sexually active fertile subjects must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n12. Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n1. Has other histologies not mentioned as part of the inclusion criteria above, i.e. HPV-independent adenocarcinoma or primary neuroendocrine.\n2. Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC, received treatment of ADC with MMAE payload, received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.\n3. Preexisting treatment related toxicity Grade ≥ 2. Subjects experienced Grade ≥ 3 immune related adverse events during or after immunotherapy.\n4. Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator.\n5. Major surgery within 28 days prior to first dose of study drug.\n6. Hemoglobin A1C (HbA1c) ≥ 8%.\n7. Preexisting peripheral neuropathy Grade ≥ 2.\n8. Any live vaccines within 28 days before first dose of study drug or during the study.\n9. Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.\n10. Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.\n11. Central nervous system metastases.\n12. History of another malignancy within 3 years before the first dose of study drug. Subjects with cured malignancies are allowed.\n13. History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.\n14. Has ocular conditions that may increase the risk of corneal epithelium damage.\n15. Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n16. Uncontrolled tumor-related bone pain or spinal cord compression.\n17. Pleural effusion, ascites or pericardial effusion with syptoms or needed drainage.\n18. Condition or situation which may put the subject at significant risk.",{"count":384,"type":20},420,[73],"The purpose of this study is to compare the efficacy and safety of 9MW2821 and chemotherapy in participants with recurrent or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.",[388],"Cervical Cancer",[390,391,392,393,394,395,396,397],"Uterine Neoplasms","Genital Neoplasms, Female","Urogenital Neoplasms","Neoplasms by Site","Neoplasms","Uterine Cervical Diseases","Uterine Diseases","Uterine Cervical Neoplasms","2024-11-20",{"date":400,"type":31},"2024-11-22",{"date":402,"type":31},"2024-09-10",{"date":134,"type":20},{"name":37,"class":38},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":287,"enrollmentInfo":412,"targetDuration":4,"studyType":21,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":423,"locationsCount":39},"100561604","phase-3-9mw2821-in-combination-with-toripalimab-vs-standard-chemotherapy-in-locally-advanced-or-metastatic-urothelial-cancer-100561604","NCT06592326","9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer","A Randomized, Controlled, Open-label, Multicenter Phase 3 Clinical Study of 9MW2821 in Combination With Toripalimab Versus Standard Chemotherapy in First-line Locally Advanced or Metastatic Urothelial Cancer","Inclusion Criteria:\n\n* Sign the informed consent form approved by IEC.\n* Male or female subjects aged 18 to 80 years.\n* ECOG status: 0 or 1.\n* Histologically confirmed local advanced or metastatic urothelial cancer\n* Previously untreated with local advanced or metastatic urothelial cancer\n* At least one measurable lesion, according to RECIST V1.1.\n* Adequate tumor tissues submitted for test\n* Suitable for cisplatin\u002Fcarboplatin-based chemotherapy assessed by investigator\n* Life expectancy for more than 12 weeks.\n* Adequate organ functions.\n* Proper contraception methods.\n* Willingness to follow the study procedures.\n\nExclusion Criteria:\n\n* History of another malignancy within 3 years.\n* History of autoimmune disease requiring systemic treatment within 2 years.\n* History of clinically significant cardiac\u002Fcerebrovascular diseases or thrombosis within 6 months.\n* Major surgery treated within 28 days; Any live vaccines got within 28 days; Radiotherapy or Intravesical therapy treated within 21 days; Traditional Chinese medicine or any potent CYP3A4 inducers\u002Finhibitors taken within 14 days.\n* Lots of pleural fluid and ascites, uncontrolled bone pain or spinal compression existed within 14 days; Systemic treatment with active infection within 7 days.\n* Previously treated with PD-1, PD-L1, PD-L2, CTLA-4 inhibitors; Previously treated with ADCs which target Nectin-4 or are conjugated with payload MMAE; Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.\n* Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.\n* Any situations adding the risk of severe dry eye, active keratitis or corneal ulcer, etc.\n* Peripheral neuropathy Grade ≥ 2.\n* Any other serious chronic or uncontrolled disease.\n* Uncontrolled central nervous system metastases or carcinomatous meningitis.\n* Active HBV\u002FHCV\u002FHIV infection, etc.\n* Known allergic sensitivity to any of the ingredients of the study drug.\n* History of drug abuse or mental illness.\n* Other conditions unsuitable into the study.",{"count":413,"type":20},460,[73],"This is a randomized, controlled, open-label, multicenter phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of 9MW2821 combined with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer.",[166],"2024-09-09",{"date":419,"type":31},"2024-09-19",{"date":421,"type":31},"2024-08-22",{"date":59,"type":20},{"name":37,"class":38},{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":287,"enrollmentInfo":431,"targetDuration":4,"studyType":21,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":39},"100522168","phase-1-9mw2821-combined-with-toripalimab-injection-in-subjects-with-local-advanced-or-metastatic-urothelial-cancer-100522168","NCT06079112","9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer","A Phase Ib\u002FII, Open-label, Single Arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of 9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer","Inclusion Criteria:\n\n* Sign and date the informed consent form e approved by independent ethics committe.\n* Male or female subjects aged 18 to 80 years (including 18 and 80 years).\n* ECOG status of 0 or 1.\n* Histologically or cytologically confirmed local advanced or metastatic urothelial cancer\n* Subjects have received at least 1 line advanced standard therapy or were not treated before\n* Subjects must submit tumor tissues for test\n* Life expectancy of ≥ 12 weeks.\n* Subjects must have measurable lesions according to RECIST (version 1.1).\n* Adequate organ functions\n* Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n* Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n* Anti-tumor treatment such as chemotherapy and radiotherapy within 21 days prior to the first dose of study drug.\n* Major surgery within 28 days prior to first dose of study drug.\n* PD-1\u002FPD-L1\u002FPD-L2 inhibitors used in the previous treatment for La\u002Fm UC.\n* Previous treatment with ADCs conjugated with MMAE payload.\n* Clinical significantly toxicity Grade ≥ 2 (except alopecia and pigmentation) related to previous treatment.\n* Peripheral neuropathy Grade ≥ 2.\n* Poorly controlled blood sugar.\n* Increased risks of corneal disease assessed by the investigator prior to the first dose of study drug.\n* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.\n* Active infections, such as uncontrolled HBV\u002FHCV\u002FHIV\u002FTB infection, etc.\n* Other serious or uncontrolled diseases, such as serious interstitial pneumonia\u002Fasthma, serious thromboembolic events, etc.\n* Poorly controlled central nervous system metastases.\n* Organ transplantation or allogeneic hematopoietic stem cell transplantation in the past.\n* History of drug abuse or mental illness.\n* Known allergic sensitivity to any of the ingredients of the study drug.\n* Any P-glycoprotein (P-gp) inducers\u002Finhibitors or potent CYP3A4 inducers\u002Finhibitors within 14 days prior to the first dose of study drug.\n* History of autoimmune disease requiring systemic treatment within 2 years before the first dose.\n* Any live vaccines within 4 weeks before first dose of study drug or during the study.\n* Use of any investigational drug or medical instruments within 28 days prior to the first dose of study drug.\n* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.\n* Other conditions unsuitable into the study.",{"count":432,"type":20},100,[50,23],"This is a phase Ib\u002FII, open-label, multicenter clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of 9MW2821 combined with Toripalimab injection in subjects with local advanced or metastatic urothelial cancer.",[250],{"date":419,"type":31},{"date":438,"type":31},"2023-09-27",{"date":440,"type":20},"2027-12-31",{"name":37,"class":38},{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":287,"enrollmentInfo":449,"targetDuration":4,"studyType":21,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":305},"100498721","phase-1-a-clinical-study-of-9mw2821-in-advanced-malignant-solid-tumors-100498721","NCT05773937","A Clinical Study of 9MW2821 in Advanced Malignant Solid Tumors","A Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of 9MW2821 in Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n* Competent to comprehend, sign, and date an independent ethics committee\u002Finstitutional review board\u002Fresearch ethics board (IEC\u002FIRB\u002FREB) approved informed consent form.\n* Male or female subjects aged 18 to 80 years (including 18 and 80 years).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Phase Ia：Histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). Phase Ib：Only local advanced or metastatic UC tumors.\n* Subjects must have received ICIs or GC\u002FGP therapies in the previous treatment.\n* Subjects must submit tumor tissues for test.\n* Life expectancy of ≥ 3 months.\n* Subjects must have measurable disease according to RECIST (version 1.1).\n* Adequate organ functions.\n* Sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.\n* Subjects are willing to follow study procedures.\n\nExclusion Criteria:\n\n* Chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug.\n* Preexisting treatment related toxicity Grade ≥ 2 (except alopecia).\n* Major surgery within 28 days prior to first dose of study drug.\n* History of uncontrolled diabetes mellitus.\n* Preexisting peripheral neuropathy Grade ≥ 2.\n* Received treatment of ADCs with MMAE payload.\n* Any live vaccines within 4 weeks before first dose of study drug or during the study.\n* Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.\n* Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.\n* Uncontrolled central nervous system metastases.\n* History of another malignancy within 3 years before the first dose of study drug. Subjects with curable malignancies are allowed.\n* History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.\n* Has ocular conditions that may increase the risk of corneal epithelium damage.\n* Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.\n* Any P-glycoprotein (P-gp) inducers\u002Finhibitors or CYP3A4 inducers\u002Finhibitors for high and medium effect within 14 days prior to the first dose of study drug.\n* Use of any investigational drug or device within 30 days prior to the first dose of study drug.\n* Conditions or situations which may put the subject at significant risk.",{"count":343,"type":20},[50],"This study is a Phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.",[453],"Advanced Malignant Solid Tumors",{"date":419,"type":31},{"date":456,"type":31},"2022-06-21",{"date":458,"type":20},"2024-12-31",{"name":37,"class":38},""]