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OncoMatch/Clinical Trials/NCT05803018

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies

Is NCT05803018 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies BL-B01D1 for gynecological malignant tumor.

Phase 1/2RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT05803018Data as of Jun 2026Location: China

Treatment: BL-B01D1A phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors, including recurrent or metastatic gynecological malignancies.

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Extracted eligibility criteria

Treatments studied

Other

BL-B01D1

Cancer type

Ovarian Cancer

Endometrial Cancer

Cervical Cancer

Tumor Agnostic

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

Must have received: standard treatment

failed standard treatment, intolerance to standard treatment, or no current standard treatment available

Cannot have received: chemotherapy

Received chemotherapy...within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.)

Cannot have received: biological therapy

Received...biological therapy...within 4 weeks or 5 half-lives prior to the first dose

Cannot have received: immunotherapy

Received...immunotherapy...within 4 weeks or 5 half-lives prior to the first dose

Cannot have received: other antitumor treatments

Received...other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose

Cannot have received: anthracycline

Cumulative anthracycline dose >360 mg/m² in prior (neo)adjuvant anthracycline therapy

Lab requirements

Blood counts

Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0; Organ function levels must meet the requirements without transfusion, albumin, colony-stimulating factors, any cell growth factors, and/or platelet-raising drugs within 14 days before the first dose of the study drug; Coagulation function: INR ≤1.5, and APTT ≤1.5 × ULN; Urine protein ≤2+ or ≤1000 mg/24h

Kidney function

Liver function

Cardiac function

No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%

No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; Organ function levels must meet the requirements...; Coagulation function: INR ≤1.5, and APTT ≤1.5 × ULN; Urine protein ≤2+ or ≤1000 mg/24h

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

Frequently asked questions

Is NCT05803018 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior chemotherapy, biological therapy, immunotherapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

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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