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

NCT07769229 | Not Yet Recruiting Phase 2

• 1 other identifier: BL-M09D1-201
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gynecological Malignancies; Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to approximately 24 months

• 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.

  Up to approximately 24 months

• 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).

  Up to approximately 24 months

Secondary Outcomes (10)

• Phase IIa: Objective Response Rate (ORR)

  Up to approximately 24 months

• Phase IIa/IIb: Progression-free Survival (PFS)

  Up to approximately 24 months

• Phase IIa/IIb: Disease Control Rate (DCR)

  Up to approximately 24 months

• Phase IIa/IIb: Duration of Response (DOR)

  Up to approximately 24 months

• Phase IIb: Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

Study Arms (1)

BL-M09D1

EXPERIMENTAL

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.

Drug: BL-M09D1

Interventions

BL-M09D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M09D1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Diagnosed with endometrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma, or other solid tumors;
• Patients with locally advanced or metastatic gynecological malignancies and other solid tumors who have failed standard treatment or are intolerant to standard treatment;
• Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group performance status of 0 or 1;
• Toxicity from prior anti-tumor therapy must have 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 protocol requirements;
• Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;
• Urine protein ≤1+ or ≤1000 mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, with serum pregnancy being negative, and they must be non-lactating; all enrolled patients (regardless of male or female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment;

You may not qualify if:

• 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;
• Diagnosis of active malignancy within 3 years prior to study randomization;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
• Hypertension inadequately controlled by two antihypertensive agents;
• Poorly controlled blood glucose;
• History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;
• Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;
• Active central nervous system metastases;
• History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M09D1;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Location

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

CN (1)