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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

BL-B01D1SI-B003

Cancer type

Cervical Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75
Female only

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.

Frequently asked questions

Is NCT05990803 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior antibody-drug conjugate with topoisomerase I inhibitor, antineoplastic therapy, mitomycin disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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