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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 (May 2026). This Phase 1/2 trial studies BL-B01D1 for gynecological malignant tumor.

Phase 1/2RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT05803018Data as of May 2026

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

Cancer type

Tumor Agnostic

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

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.

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