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.
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;
Received chemotherapy, targeted therapy, biological therapy, etc. within 4 weeks or 5 half-lives before the first dose;
History of severe heart disease;
Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block; frequent and uncontrollable arrhythmias;
Active autoimmune disease or inflammatory disease;
Single group
BL-M09D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
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.
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/or 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.
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).
Phase IIa: 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).
Phase IIa/IIb: 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.
Phase IIa/IIb: 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.
Phase IIa/IIb: 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.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
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