Tests BL-B01D1 in adults with solid tumors, including gynecological cancers
Tests the drug BL-B01D1 in adults with solid tumors, including gynecological cancers.
Plain-language title generated from the registry record
Registry title: A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 with recurrent or metastatic gynecological cancer. Standard treatment must have failed, not been tolerated, or not exist for them.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Gynecological cancer that has come back or spread, confirmed by tissue or cell tests. At least one lesion that can be measured (RECIST v1.1).
- Earlier treatment
- Standard treatment failed, was not tolerated, or none is available. Side effects from earlier cancer treatment must have recovered to Grade 1 or less.
Main reasons for not taking part
- Spread to the brain or its lining (CNS metastases or carcinomatous meningitis)
- History of interstitial lung disease or severe heart disease
- Previous organ transplant or allogeneic stem cell transplant
- HIV-positive, or active tuberculosis, hepatitis B or hepatitis C
- Cancer treatment within 4 weeks or 5 half-lives before the first dose
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05803018, who can take part
Where in China
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT05803018
- Record updated
- 26 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.); Other malignancies with progression or requiring treatment within 5 years prior to the first dose; Concurrent pulmonary disease leading to clinically significant respiratory impairment; Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); Cumulative anthracycline dose >360 mg/m² in prior (neo)adjuvant anthracycline therapy; 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; History of severe heart disease; Active autoimmune or inflammatory diseases; Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg) despite the use of two antihypertensive medications; History of interstitial lung disease (ILD), current ILD, or suspected ILD based on imaging during screening; History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-B01D1; Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection; Any other condition deemed unsuitable for participation in this clinical trial by the investigator; Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia; Poorly controlled blood glucose levels; 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; Imaging findings indicating tumor invasion or encasement of major thoracic, cervical, or pharyngeal blood vessels.