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

A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Recurrent or Metastatic Gynecological Malignancies and Other Solid Tumors

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.

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.