About this trial
This study is a single-arm, open-label, multicenter, non-randomized phase II clinical study evaluating the efficacy and safety of BL-M09D1 for injection in patients with locally advanced or metastatic gynecological malignancies and other solid tumors.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
Female;
Age: ≥18 years and ≤75 years;
Expected survival time ≥3 months;
Disqualifiers
Use of chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
History of severe heart disease;
Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;
Active autoimmune disease or inflammatory disease;
Trial design
Treatments tested in this trial
- BL-M09D1
Treatment groups
Sponsors and collaborators
Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator