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OncoMatch/Clinical Trials/NCT05990803

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

Is NCT05990803 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including BL-B01D1 and SI-B003 for cervical cancer.

Phase 2RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT05990803Data as of May 2026

Treatment: BL-B01D1 · SI-B003Objective: 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.

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Extracted eligibility criteria

Cancer type

Cervical Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard treatment

after failure or intolerance to standard treatment or for which no standard treatment is available

Cannot have received: antibody-drug conjugate with topoisomerase I inhibitor

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

Cannot have received: antineoplastic therapy

Exception: within 4 weeks or 5 half-lives before the first dose

Use of antineoplastic therapy within 4 weeks or 5 half-lives before the first dose

Cannot have received: mitomycin (mitomycin)

Exception: within 6 weeks before the first dose

Mitomycin and nitrosoureas were administered within 6 weeks before the first dose

Cannot have received: nitrosoureas (nitrosoureas)

Exception: within 6 weeks before the first dose

Mitomycin and nitrosoureas were administered within 6 weeks before the first dose

Cannot have received: oral fluorouracil (oral fluorouracil)

Exception: within 2 weeks before the first dose

Oral fluorouracil or palliative radiotherapy within 2 weeks before the first dose

Cannot have received: palliative radiotherapy

Exception: within 2 weeks before the first dose

Oral fluorouracil or palliative radiotherapy within 2 weeks before the first dose

Cannot have received: immunomodulatory drug

Exception: within 14 days before the first dose of study drug (Cohort_B, Cohort_C only)

Cohort_B, Cohort_C, who had received an immunomodulatory drug within 14 days before the first dose of study drug

Lab requirements

Cardiac function

no severe cardiac dysfunction, left ventricular ejection fraction ≥50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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