[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657309":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":55,"interventions":62,"overallOfficials":48,"centralContacts":67,"locations":73,"responsibleParty":89,"collaborators":91,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":48,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":48,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":48,"overallStatus":114,"whyStopped":48,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Sichuan Baili Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":48},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Phase IIa: Recommended Phase II Dose (RP2D)","The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M09D1.","Up to approximately 24 months",{"measure":14,"description":15,"timeFrame":12},"Phase IIa: Treatment-Emergent Adverse Event (TEAE)","TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and\u002For intensity) of a pre-existing condition during the treatment of BL-M09D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M09D1.",{"measure":17,"description":18,"timeFrame":12},"Phase IIb: Objective Response Rate (ORR)","Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).",[20,22,25,28,31,33,36,39,42,45],{"measure":21,"description":18,"timeFrame":12},"Phase IIa: Objective Response Rate (ORR)",{"measure":23,"description":24,"timeFrame":12},"Phase IIa\u002FIIb: Progression-free Survival (PFS)","Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.",{"measure":26,"description":27,"timeFrame":12},"Phase IIa\u002FIIb: Disease Control Rate (DCR)","Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.",{"measure":29,"description":30,"timeFrame":12},"Phase IIa\u002FIIb: Duration of Response (DOR)","Duration of Response (DOR) is defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.",{"measure":32,"description":15,"timeFrame":12},"Phase IIb: Treatment-Emergent Adverse Event (TEAE)",{"measure":34,"description":35,"timeFrame":12},"Cmax","Cmax is defined as the maximum observed drug concentration in plasma after administration.",{"measure":37,"description":38,"timeFrame":12},"Tmax","Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.",{"measure":40,"description":41,"timeFrame":12},"Ctrough","Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.",{"measure":43,"description":44,"timeFrame":12},"Anti-drug Antibody (ADA)","Frequency of anti-BL-M09D1 antibody (ADA) will be investigated.",{"measure":46,"description":47,"timeFrame":12},"Neutralizing Antibody(NAb)","Frequency of anti-BL-M09D1 neutralizing antibodies will be investigated.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"NA","SINGLE_GROUP","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":48},"NONE",[56],{"label":57,"type":58,"description":59,"interventionNames":60},"BL-M09D1","EXPERIMENTAL","Participants receive BL-M09D1 for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.",[61],"Drug: BL-M09D1",[63],{"type":64,"name":57,"description":65,"armGroupLabels":66,"otherNames":48},"DRUG","Administration by intravenous infusion for a cycle of 3 weeks.",[57],[68],{"name":69,"role":70,"phone":71,"phoneExt":48,"email":72},"Sa Xiao, PHD","CONTACT","+86 15013238943","xiaosa@baili-pharm.com",[74],{"facility":75,"status":48,"city":76,"state":77,"zip":48,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Sun Yat-sen Memorial Hospital, Sun Yat-sen University","Guangzhou","Guangdong","China","CN",{"type":81,"coordinates":82},"Point",[83,84],113.25,23.11667,{"lat":84,"lon":83},[87],{"name":88,"role":70,"phone":48,"phoneExt":48,"email":48},"Tianxin Lin",{"type":90,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[92],{"name":93,"class":6},"Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.","100657309","phase-2-a-study-of-bl-m09d1-in-patients-with-locally-advanced-or-metastatic-urothelial-carcinoma-and-other-solid-tumors-100657309",false,"NCT07837622","A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors","A Phase IIa\u002FIIb Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and comply with the protocol requirements;\n2. Age: ≥18 years and ≤75 years;\n3. Expected survival time ≥3 months;\n4. Locally advanced or metastatic urothelial carcinoma and other solid tumors;\n5. Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesion within 2 years;\n6. Must have at least one measurable lesion as defined by RECIST v1.1;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n8. Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0;\n9. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;\n10. Organ function levels must meet the requirements;\n11. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 ULN;\n12. For premenopausal female trial participants of childbearing potential, a serum pregnancy test must be performed within 7 days before the start of treatment. The serum pregnancy test must exclude pregnancy, and the participant must not be breastfeeding; all enrolled trial participants and their partners must agree to use adequate highly effective contraceptive measures throughout the entire treatment period and for 7 months (women) and 4 months (men) after the end of treatment. It is recommended to also use other contraceptive methods, such as barrier contraception;\n13. Trial participants are able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.\n\nExclusion Criteria:\n\n1. Received chemotherapy, targeted therapy, biological therapy, etc. within 4 weeks or 5 half-lives before the first dose;\n2. History of severe heart disease;\n3. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block; frequent and uncontrollable arrhythmias;\n4. Active autoimmune disease or inflammatory disease;\n5. Diagnosed with other malignancies within 5 years before the first dose;\n6. Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose;\n7. Hypertension poorly controlled by two antihypertensive drugs;\n8. Patients with poorly controlled blood glucose;\n9. History of interstitial lung disease requiring hormone therapy, or current ILD or grade \\>= 2 radiation pneumonitis;\n10. Concurrent lung disease causing clinically severe impairment of respiratory function;\n11. Active central nervous system metastasis;\n12. Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M09D1;\n13. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;\n14. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;\n15. Active infection requiring systemic treatment within 4 weeks before the first study drug administration;\n16. Pleural, abdominal, pelvic effusion, or pericardial effusion requiring drainage and\u002For accompanied by symptoms within 4 weeks before the first study drug administration;\n17. Participated in another clinical trial within 4 weeks or 5 half-lives before the first dose;\n18. Trial participants with clinically significant bleeding or a clear bleeding tendency within 4 weeks before the first study drug administration;\n19. Inflammatory bowel disease with symptoms or requiring drug intervention, or partial or complete intestinal obstruction, within 4 weeks before the first study drug administration;\n20. Known mental illness or disorder that may affect trial compliance;\n21. Trial participants planning to receive vaccination or who received a live vaccine within 28 days before the first dose;\n22. Pregnant or breastfeeding women;\n23. Other circumstances in which the investigator considers the patient unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":105,"type":106},42,"ESTIMATED","INTERVENTIONAL",[109],"PHASE2","This study is a single-arm, open-label, multicenter, non-randomized phase IIa\u002FIIb clinical study to evaluate the efficacy and safety of BL-M09D1 for injection in patients with locally advanced or metastatic urothelial carcinoma and other solid tumors.",[112,113],"Urothelial Carcinoma (UC)","Solid Tumors","NOT_YET_RECRUITING","2026-09-18",{"date":117,"type":118},"2026-09-23","ACTUAL",{"date":120,"type":106},"2026-09",{"date":122,"type":106},"2028-12",{"name":5,"class":6},1]