Actively Recruiting
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
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-09-26
38
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of BL-B01D1, an intravenous drug, in patients with multiple solid tumors, including recurrent or metastatic gynecological cancers. This phase Ib/II clinical study aims to find the recommended dose for further trials and assess the drug's initial effects and immune response in these patients. Participants receive BL-B01D1 by intravenous infusion during the first 3-week treatment cycle. Patients who show clinical benefit may continue receiving additional cycles until disease progression, intolerable side effects, or other reasons for stopping treatment occur. The study includes two phases: Phase Ib focuses on safety and dose finding, while Phase II explores efficacy at the recommended dose. During the study, researchers will monitor participants for treatment effects, side effects, and how the drug behaves in the body. They will collect tumor tissue samples, measure tumor response, and assess survival indicators for up to about 24 months. Safety monitoring includes evaluating adverse events and immune reactions. Participants will be followed regularly to assess treatment outcomes and overall health throughout the study period.
CONDITIONS
Brief Title
A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and follow study rules
- Aged 18 to 75 years
- Expected survival time of at least 3 months
- Histologically or cytologically confirmed recurrent or metastatic gynecological malignancies with prior treatment failure, intolerance, or no current standard treatment
- Agree to provide archived or fresh tumor tissue samples from the past 3 years
- At least one measurable tumor lesion per RECIST v1.1
- ECOG performance status score of 0 or 1
- Side effects from previous cancer therapy recovered to Grade 1 or less
- No severe cardiac dysfunction with left ventricular ejection fraction of 50% or higher
- Adequate organ function without recent transfusions or growth factor treatments
- Coagulation function with INR ≤1.5 and APTT ≤1.5 times upper limit of normal
- Urine protein ≤2+ or ≤1000 mg/24h
- For premenopausal women with childbearing potential, negative pregnancy test and agreement to use contraception during and 6 months after treatment
You will not qualify if you...
- Received chemotherapy, biological therapy, immunotherapy, or other anticancer treatments within 4 weeks or 5 half-lives prior to first dose (6 weeks for certain drugs)
- 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 progressing or recently treated malignancies within 5 years
- Poorly controlled hypertension despite two medications
- Poorly controlled blood glucose levels
- History or suspicion of interstitial lung disease
- Significant pulmonary disease causing respiratory impairment
- Unstable thrombotic events within 6 months before screening
- Central nervous system metastases or carcinomatous meningitis
- Significant or uncontrolled serous cavity effusion
- Hypersensitivity to recombinant humanized antibodies or BL-B01D1 components
- Tumor invasion or encasement of major blood vessels
- Previous organ or stem cell transplantation
- High cumulative prior anthracycline dose
- Positive for HIV, active tuberculosis, or active hepatitis B or C infections
- Severe infection within 4 weeks before first dose
- Participation in another clinical trial within 4 weeks before first dose
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - First cycle lasts 3 weeks; additional cycles continue until disease progression or intolerable toxicity
Participants receive BL-B01D1 as an intravenous infusion for the first 3-week cycle. Those who benefit may receive additional cycles until disease progression, intolerable toxicity, or other reasons for stopping treatment.
Visits corresponding to each infusion cycle; exact number depends on treatment duration
Trial Site Locations
Total: 1 location
1
Fudan University ShangHai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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