Tests BL-M09D1 in people with advanced urothelial carcinoma and other solid tumors

Trial details

Who runs it

Sichuan Baili Pharmaceutical Co., Ltd.

Trial code

NCT07837622

Record updated

23 September 2026

Original description

This study is a single-arm, open-label, multicenter, non-randomized phase IIa/IIb 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.Read full original descriptionShow less

A Phase IIa/IIb 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

This study is a single-arm, open-label, multicenter, non-randomized phase IIa/IIb 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.

Inclusion: Voluntarily sign the informed consent form and comply with the protocol requirements; Age: ≥18 years and ≤75 years; Expected survival time ≥3 months; Locally advanced or metastatic urothelial carcinoma and other solid tumors; Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesion within 2 years; Must have at least one measurable lesion as defined by RECIST v1.1; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0; No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; Organ function levels must meet the requirements; Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 ULN; 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; 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.

Exclusion: Received chemotherapy, targeted therapy, biological therapy, etc. within 4 weeks or 5 half-lives before the first dose; Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose; Concurrent lung disease causing clinically severe impairment of respiratory function; Previous organ transplantation or allogeneic hematopoietic stem cell transplantation; Active infection requiring systemic treatment within 4 weeks before the first study drug administration; Pleural, abdominal, pelvic effusion, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks before the first study drug administration; Trial participants with clinically significant bleeding or a clear bleeding tendency within 4 weeks before the first study drug administration; Inflammatory bowel disease with symptoms or requiring drug intervention, or partial or complete intestinal obstruction, within 4 weeks before the first study drug administration; Trial participants planning to receive vaccination or who received a live vaccine within 28 days before the first dose; History of severe heart disease; Active autoimmune disease or inflammatory disease; Diagnosed with other malignancies within 5 years before the first dose; Hypertension poorly controlled by two antihypertensive drugs; History of interstitial lung disease requiring hormone therapy, or current ILD or grade >= 2 radiation pneumonitis; Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M09D1; Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; Known mental illness or disorder that may affect trial compliance; Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block; frequent and uncontrollable arrhythmias; Patients with poorly controlled blood glucose; Active central nervous system metastasis; Participated in another clinical trial within 4 weeks or 5 half-lives before the first dose; Pregnant or breastfeeding women; Other circumstances in which the investigator considers the patient unsuitable for participation in this clinical trial.

ClinicalTrials.gov NCT07837622