A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

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

126 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator