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

Recruiting now · Phase 1/Phase 2

Conditions studied: Gynecological Malignant Tumor, Solid Tumor

In brief

A 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.

Key facts

Study ID

NCT05803018

Run by

Sichuan Baili Pharmaceutical Co., Ltd.

People needed

38

Starts

2023-06-25

Expected to finish

2027-12-01

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Histologically and/or cytologically confirmed recurrent or metastatic gynecological malignancies with failed standard treatment, intolerance to standard treatment, or no current standard treatment available;
• Agree to provide archived tumor tissue specimens (10 slides) or fresh tissue samples from primary or metastatic lesions within the past 3 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• 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: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
• Urine protein ≤2+ or ≤1000 mg/24h;
• For premenopausal women with childbearing potential, a pregnancy test (serum or urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.

You may not qualify if…

• Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.);
• History of severe heart disease;
• Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia;
• Active autoimmune or inflammatory diseases;
• Other malignancies with progression or requiring treatment within 5 years prior to the first dose;
• Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) despite the use of two antihypertensive medications;
• Poorly controlled blood glucose levels;
• History of interstitial lung disease (ILD), current ILD, or suspected ILD based on imaging during screening;
• Concurrent pulmonary disease leading to clinically significant respiratory impairment;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (leptomeningeal metastases);
• Patients with significant serous cavity effusion, symptomatic effusion, or poorly controlled effusion;
• History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-B01D1;
• Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or pharyngeal blood vessels;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• Cumulative anthracycline dose >360 mg/m² in prior (neo)adjuvant anthracycline therapy;
• Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection;
• Severe infection within 4 weeks before the first dose of the study drug; signs of active pulmonary infection within 2 weeks before the first dose;
• Participation in another clinical trial within 4 weeks before the first dose;
• Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

Where it is running

• Fudan University ShangHai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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