A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervic… (NCT05990803) | Clinical Trial Compass
RecruitingPhase 2
A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies
China130 participantsStarted 2023-11-06
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Subject volunteered to participate in the study and signed an informed consent;
✓. Women aged ≥18 years and ≤75 years;
✓. Expected survival time ≥3 months;
✓. ECOG score 0-1;
✓. 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;
✓. Agree to provide 10 surgical specimens or fresh tissue samples of primary or metastatic tumors within 3 years;
✓. At least one measurable lesion meeting the RECIST v1.1 definition was required;
✓. 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;
Exclusion criteria
✕. Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
✕. 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;
✕. Cohort\_B and Cohort\_C with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis;