A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

Inclusion Criteria:

1. Subject volunteered to participate in the study and signed an informed consent;

2. Women aged ≥18 years and ≤75 years;

3. Expected survival time ≥3 months;

4. ECOG score 0-1;

5. Gynecological malignancies such as recurrent or metastatic cervical cancer confirmedby histopathology and/or cytology after failure or intolerance to standard treatmentor for which no standard treatment is available;

6. Agree to provide 10 surgical specimens or fresh tissue samples of primary ormetastatic tumors within 3 years;

7. At least one measurable lesion meeting the RECIST v1.1 definition was required;

8. No blood transfusion, colony-stimulating factor, any cell growth factor injection,or albumin injection were allowed within 14 days before the first use of the studydrug, and the organ function level must meet the requirements;

9. Urine protein ≤2+ or ≤1000g/24h;

10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

11. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as definedby NCI-CTCAE v5.0;

12. For premenopausal women with childbearing potential, a pregnancy test must beperformed within 7 days before starting treatment, a serum or urine pregnancy testmust be negative, and the patient must not be lactating; All enrolled patientsshould take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Exclusion Criteria:

1. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;

2. Use of antineoplastic therapy within 4 weeks or 5 half-lives before the first dose;Mitomycin and nitrosoureas were administered within 6 weeks before the first dose;Oral fluorouracil or palliative radiotherapy within 2 weeks before the first dose;

3. Cohort_B and Cohort_C with a history of immunotherapy and grade ≥3 irAE or grade ≥2immune-related myocarditis;

4. Cohort_B, Cohort_C, who had received an immunomodulatory drug within 14 days beforethe first dose of study drug;

5. Had a history of serious cardiovascular and cerebrovascular diseases;

6. Active autoimmune and inflammatory diseases;

7. Other malignant tumors that progressed or required treatment within 5 years beforethe first dose;

8. A history of ILD requiring steroid therapy, current ILD, or suspected ILD atscreening that could not be ruled out by imaging;

9. History of poorly controlled diabetes mellitus, poorly controlled hypertension, orhypertensive crisis or hypertensive encephalopathy before the first medication;

10. New onset of deep vein thrombosis within 14 days before screening or pulmonaryembolism within 6 months;

11. Patients with active central nervous system metastases;

12. Patients with massive, symptomatic, poorly controlled, or unstable effusions;

13. Patients with a history of allergy to recombinant humanized antibody or human-mousechimeric antibody or to any of BL-B01D1's excipients;

14. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;

15. Human immunodeficiency virus antibody positive, active tuberculosis, activehepatitis B virus infection or active hepatitis C virus infection;

16. Active infections requiring systemic therapy, such as severe pneumonia, bacteremia,sepsis, etc;

17. Had participated in another clinical trial within 4 weeks before the first dose;

18. Who have a history of psychotropic drug abuse and cannot quit or have mentaldisorders;

19. Patients with a history of intestinal obstruction within 6 months before thescreening period;

20. Other circumstances that the investigator deemed inappropriate for participation inthe trial.