A Study of BL-M08D1 in Patients With Recurrent or Metastatic Gynecological Malignancies and Other Solid Tumors

NCT07793825 | Not Yet Recruiting Phase 1

• 1 other identifier: BL-M08D1-203
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase Ib/II study is a clinical study to explore the efficacy and safety of BL-M08D1 for injection in patients with recurrent or metastatic gynecological tumors and other solid tumors.

Conditions

Gynecological Tumors; Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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-M08D1.

  Up to approximately 24 months

• Objective Response Rate (ORR)

  ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

  Up to approximately 24 months

Secondary Outcomes (11)

• Progression-free Survival (PFS)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

• Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Cmax

  Up to approximately 24 months

Study Arms (1)

BL-M08D1

EXPERIMENTAL

Participants receive BL-M08D1 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-M08D1

Interventions

BL-M08D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-M08D1

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 follow the protocol requirements;
• Female;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Recurrent or metastatic gynecological malignancies and other solid tumors;
• Agree to provide archived tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Toxicities 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 required criteria;
• Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN;
• Urine protein ≤2+ or ≤1000 mg/24h;
• For premenopausal women of childbearing potential, a serum pregnancy test must be negative within 7 days before starting treatment, and they must not be breastfeeding; all enrolled patients must use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment completion;
• The trial participant is capable and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures as specified in the protocol.

You may not qualify if:

• Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
• History of severe heart disease or cerebrovascular disease within 6 months before screening;
• Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of another malignancy within 5 years prior to the first dose;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
• Hypertension inadequately controlled by antihypertensive medication;
• Poorly controlled blood glucose;
• History of interstitial lung disease requiring corticosteroid therapy, or currently having ILD or grade ≥2 radiation pneumonitis;
• Severe impairment of respiratory function;
• Active central nervous system metastases;
• History of or coexisting central nervous system lesions;
• History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1;
• Previous 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;

Sponsors & Collaborators

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

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Sa Xiao, PHD

CONTACT

+86 15013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

CN (1)