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Clinical Trials in China / NCT07793825
Starting soon Phase 1/2

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

NCT07793825 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Phase
Phase 1/2
Started
2026-09
Last updated
2026-08-31

Condition(s) studied

Gynecological TumorsSolid Tumors

Investigational drug(s) / intervention(s)

BL-M08D1

BL-M08D1: Administration by intravenous infusion for a cycle of 3 weeks.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily sign the informed consent form and agree to follow the protocol requirements; 2. Female; 3. Age: ≥18 years and ≤75 years; 4. Expected survival time ≥3 months; 5. Recurrent or metastatic gynecological malignancies and other solid tumors; 6. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 3 years, or fresh tissue samples; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0; 10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%; 11. Organ function levels must meet the required criteria; 12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × ULN; 13. Urine protein ≤2+ or ≤1000 mg/24h; 14. 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; 15. 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. Exclusion Criteria: 1. Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose; 2. History of severe heart disease or cerebrovascular disease within 6 months before screening; 3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block; 4. Active autoimmune diseases and inflammatory diseases; 5. Diagnosis of another malignancy within 5 years prior to the first dose; 6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose; 7. Hypertension inadequately controlled by antihypertensive medication; 8. Poorly controlled blood glucose; 9. History of interstitial lung disease requiring corticosteroid therapy, or currently having ILD or grade ≥2 radiation pneumonitis; 10. Severe impairment of respiratory function; 11. Active central nervous system metastases; 12. History of or coexisting central nervous system lesions; 13. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M08D1; 14. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation; 15. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 16. Active infection requiring systemic therapy within 4 weeks prior to the first dose of the study drug; 17. Pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first dose of the study drug; 18. Imaging findings indicating tumor invasion or encasement of abdominal, thoracic, or other regions; 19. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose; 20. Pregnant or breastfeeding women; 21. Other conditions that, in the investigator's judgment, make the patient unsuitable for participation in this clinical trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Cancer Hospital Hangzhou Zhejiang

More Sichuan Baili Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07793825 on ClinicalTrials.gov ↗ ← All trials in China