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

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07769229
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gynecological Malignancies
  • Solid Tumors

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-M09D1 — DRUG
    Administration by intravenous infusion for a cycle of 3 weeks.

Study Details

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.

Key Dates

First listed
Aug 17, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BL-M09D1
    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.

Primary Outcome Measure

Phase IIa: Recommended Phase II Dose (RP2D) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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