A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies
Trial Parameters
Brief Summary
Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination.
Eligibility Criteria
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 confirmed by histopathology and/or cytology after failure or intolerance to standard treatment or for which no standard treatment is available; 6. Agree to provide 10 surgical specimens or fresh tissue samples of primary or metastatic 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 study drug, 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 antineopla