Actively Recruiting
A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-11-17
260
Participants Needed
1
Research Sites
122 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
This Phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 in combination with tyrosine kinase inhibitor (TKI) with or without pembrolizumab (BL-B01D1+TKI±Pembrolizumab) in patients with locally advanced or metastatic renal cancer.
CONDITIONS
Official Title
A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteered and signed informed consent
- Male or female aged 18 to 75 years
- Expected survival time of at least 3 months
- ECOG performance status of 0 or 1
- Diagnosed with locally advanced or metastatic renal cell carcinoma confirmed by histopathology or cytology
- Willing to provide archived or fresh tumor tissue samples from primary or metastatic lesions within 3 years
- At least one measurable lesion according to RECIST v1.1 criteria
- Adequate organ function
- Toxicity from previous cancer treatments has resolved to grade 1 or less per NCI-CTCAE v5.0
- Fertile participants agree to use effective contraception from 7 days before first dose until 7 months after first dose; females of childbearing potential must have a negative serum pregnancy test within 7 days before first dose
You will not qualify if you...
- Received chemotherapy, biological therapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose; mitomycin and nitrosoureas within 6 weeks; oral drugs like fluorouracil
- Prior treatment with antibody-drug conjugates containing camptothecin derivatives
- Use of immunomodulatory drugs within 14 days before first dose
- History of severe cardiovascular or cerebrovascular disease within 6 months before screening
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent uncontrollable arrhythmia
- Active autoimmune or inflammatory diseases
- Need for systemic corticosteroids or immunosuppressive agents within 2 weeks before first dose
- Other cancers within 5 years before first dose
- History or current interstitial lung disease requiring steroids or suspected ILD
- Poorly controlled or severe diabetes complications
- Unstable thrombotic events requiring treatment within 6 months before screening
- Pulmonary diseases causing severe respiratory impairment
- Active central nervous system metastasis
- Large or symptomatic effusions not well controlled
- Allergy to humanized antibodies, BL-B01D1, pembrolizumab, or related excipients
- Previous allogeneic stem cell, bone marrow, or organ transplant
- Positive for HIV, active tuberculosis, or active hepatitis B or C infection
- Serious infection within 4 weeks before first dose or active pulmonary infection at screening
- Participation in another clinical trial within 4 weeks before first dose
- History of psychotropic drug abuse or severe neurological/psychiatric illness
- Tumor invasion or encasement of major thoracic vessels
- Serious unhealed wounds, ulcers, or fractures within 4 weeks before consent
- Significant bleeding or bleeding tendency within 4 weeks before consent
- Scheduled to receive live vaccine or received within 28 days before first dose
- Other serious physical or lab abnormalities or poor compliance increasing study risk or interfering with results
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
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here