Actively Recruiting
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 in Combination With Tyrosine Kinase Inhibitor (TKI) With or Without 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
30 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 and effectiveness of BL-B01D1 combined with a tyrosine kinase inhibitor (TKI), with or without pembrolizumab, in patients who have locally advanced or metastatic renal cancer. This Phase II clinical study aims to explore how well this combination works and monitor any side effects in this patient group. The study is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. Participants receive BL-B01D1 through intravenous infusion in 3-week cycles, combined with either axitinib taken orally twice daily or lenvatinib taken orally once daily. Pembrolizumab may also be given by intravenous infusion every 3 weeks. Those who show clinical benefit may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons require stopping treatment. During the trial, patients will be closely monitored for tumor response, side effects, and drug levels for up to approximately 24 months. Researchers will assess outcomes such as objective response rate, progression-free survival, disease control, duration of response, and overall survival. Safety will be tracked by recording treatment-emergent adverse events. Participants will provide tumor tissue samples and undergo regular evaluations to help determine the study's results.
CONDITIONS
Brief 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...
- Subject volunteered to participate in the study and signed an informed consent
- Male or female aged 6518 years and 6575 years
- Expected survival time 653 months
- ECOG score 0 or 1
- Patients with locally advanced or metastatic renal cell carcinoma confirmed by histopathology and/or cytology
- Agree to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years
- At least one measurable lesion meeting the RECIST v1.1 definition was required
- Organ function level must meet the requirements
- The toxicity of previous antineoplastic therapy has returned to 64 grade 1 as defined by NCI-CTCAE v5.0
- Fertile female subjects, or male subjects with fertile partners, must use highly effective contraception from 7 days before the first dose until 7 months after the first dose
- Female subjects of childbearing potential had to have a negative serum pregnancy test within 7 days before the first dose
You will not qualify if you...
- Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose
- Mitomycin and nitrosoureas were administered within 6 weeks before the first dose
- Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin
- Use of immunomodulatory drugs within 14 days before the first dose of study drug
- History of severe cardiovascular and cerebrovascular diseases within six months before screening
- Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia
- Active autoimmune and inflammatory diseases
- Systemic corticosteroids or immunosuppressive agents required within 2 weeks before the first dose
- Other malignant tumors within 5 years before the first dose
- History of non-infectious ILD requiring steroid treatment, or current ILD/interstitial pneumonia or suspected ILD
- Poorly controlled diabetes or severe diabetes complications before starting study treatment
- Unstable thrombotic events requiring intervention within 6 months before screening
- Pulmonary diseases causing severe respiratory impairment
- Active central nervous system metastasis
- Massive or symptomatic effusions or poorly controlled effusions
- History of allergy to recombinant humanized antibody, human-mouse chimeric antibody, BL-B01D1, or pembrolizumab excipients
- Previous allogeneic stem cell, bone marrow or organ transplantation
- Positive for HIV antibody, active tuberculosis, active hepatitis B or C infection
- Serious infection within 4 weeks before first dose or active pulmonary inflammation at screening
- Participation in another clinical trial within 4 weeks before first dose
- History of psychotropic drug abuse or severe neurological or psychiatric illness
- Tumor invasion or wrapping of large thoracic vessels
- Serious unhealed wound, ulcer, or fracture within 4 weeks before consent
- Clinically significant bleeding or bleeding tendency within 4 weeks before consent
- Scheduled to receive live vaccine or received one within 28 days before first dose
- Other serious physical or laboratory 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive BL-B01D1 combined with a tyrosine kinase inhibitor (TKI) with or without Pembrolizumab. Treatment cycles last 3 weeks each. Participants who show clinical benefit may continue treatment for additional cycles until disease progression, intolerable toxicity, or other reasons for stopping.
1 visit per treatment cycle (in-person)
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
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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