Actively Recruiting
A Study of BL-B01D1 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
231 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
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.
CONDITIONS
Official 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...
- Signed informed consent and willing to follow study rules
- Age between 18 and 75 years
- Expected to live at least 3 months
- Confirmed recurrent or metastatic gynecological cancer after standard treatments have failed or are not available
- Agree to provide tumor tissue samples from the past 3 years
- Have at least one measurable tumor lesion
- ECOG performance status of 0 or 1
- Side effects from previous treatments have improved to Grade 1 or less
- No severe heart dysfunction with LVEF of 50% or higher
- Organ functions adequate without recent transfusions or growth factor drugs
- Coagulation tests within specified limits
- Urine protein levels within allowed range
- Premenopausal women must have a negative pregnancy test and not be breastfeeding; all patients must use contraception during and 6 months after treatment
You will not qualify if you...
- Received chemotherapy, biological therapy, immunotherapy, or other cancer treatments within 4 weeks or 5 half-lives before starting
- History of severe heart disease
- Abnormal heart rhythms or conduction problems
- Active autoimmune or inflammatory diseases
- Other active cancers needing treatment within 5 years
- Poorly controlled high blood pressure despite medication
- Poorly controlled blood sugar levels
- History or signs of interstitial lung disease
- Lung diseases causing significant breathing problems
- Recent unstable blood clots within 6 months
- Brain metastases or carcinomatous meningitis
- Significant or uncontrolled fluid buildup in body cavities
- Allergy to similar antibodies or study drug components
- Tumor invading major blood vessels
- Previous organ or stem cell transplant
- High prior doses of anthracycline chemotherapy
- Positive for HIV, active tuberculosis, or active hepatitis B or C
- Recent severe infection or active lung infection
- Participation in another clinical trial within 4 weeks
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University ShangHai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
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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