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

A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M09D1 for Injection in Patients With Locally Advanced or Metastatic Gynecological Malignancies and Other Solid Tumors

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.

Inclusion Criteria:

1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
2. Female;
3. Age: ≥18 years and ≤75 years;
4. Expected survival time ≥3 months;
5. Diagnosed with endometrial cancer, cervical cancer, ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma, or other solid tumors;
6. Patients with locally advanced or metastatic gynecological malignancies and other solid tumors who have failed standard treatment or are intolerant to standard treatment;
7. Agree to provide archived tumor tissue specimens from the primary or metastatic site within 2 years, or fresh tissue samples;
8. Must have at least one measurable lesion as defined by RECIST v1.1;
9. Eastern Cooperative Oncology Group performance status of 0 or 1;
10. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
11. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
12. Organ function levels must meet the protocol requirements;
13. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 × upper limit of normal;
14. Urine protein ≤1+ or ≤1000 mg/24h;
15. 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;
16. The trial participant is capable and willing to comply with the scheduled visits, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.

Exclusion Criteria:

1. Use of chemotherapy, targeted therapy, biologic therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
2. History of severe heart disease;
3. Prolonged QT interval, complete left bundle branch block, or third-degree atrioventricular block;
4. Active autoimmune disease or inflammatory disease;
5. Diagnosis of active malignancy within 3 years prior to study randomization;
6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
7. Hypertension inadequately controlled by two antihypertensive agents;
8. Poorly controlled blood glucose;
9. History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or grade ≥2 radiation pneumonitis;
10. Concurrent pulmonary disease resulting in clinically severe impairment of respiratory function;
11. Active central nervous system metastases;
12. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M09D1;
13. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
14. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
15. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;
16. Pleural, abdominal, or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration;
17. Participation in another clinical trial within 4 weeks or 5 half-lives prior to the first dose;
18. Clinically significant bleeding or marked bleeding tendency within 4 weeks prior to the first study drug administration;
19. Inflammatory bowel disease requiring symptomatic or drug intervention, or partial/complete intestinal obstruction within 4 weeks prior to the first study drug administration;
20. Known psychiatric disorders that may affect compliance with the trial;
21. Planned vaccination or administration of live vaccine within 28 days prior to the first dose;
22. Pregnant or breastfeeding women;
23. Other conditions deemed by the investigator to make the participant unsuitable for enrollment in this clinical trial.