Actively Recruiting
An Open, Multicenter Phase Ib/II Clinical Study of SHR-8068 in Combination With Adebrelimab and Other Anti-tumor Drugs for the Treatment of Advanced Renal Cell Carcinoma
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-16
139
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of SHR-8068 combined with Adebrelimab and other anti-tumor drugs for treating advanced renal cell carcinoma, a type of kidney cancer that has spread or cannot be removed by surgery. This open, multicenter clinical trial includes adults aged 18 to 75 years with confirmed advanced clear cell renal cell carcinoma and aims to assess how well these drug combinations work and how safe they are. Participants will receive one of three experimental treatments: SHR-8068 with Adebrelimab and Bevacizumab; SHR-8068 with Adebrelimab and HS-10516; or SHR-8068 with Adebrelimab, Bevacizumab, and HRS-10516. The study is non-randomized and involves administering these drugs to evaluate their combined effects on the cancer. During the study, participants will be closely monitored for dose-limiting toxicities within 21 days of treatment start and overall response rate until disease progression or death for up to three years. Additional assessments include progression-free survival, duration of response, disease control rate, and the incidence and severity of adverse events up to 90 days after the last dose. The total participation duration varies depending on these outcomes and monitoring schedules.
CONDITIONS
Brief Title
Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Other Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old (including boundary values)
- Volunteered and signed informed consent
- ECOG score of 0-1
- Expected survival of at least 3 months
- Diagnosed with locally advanced unresectable or metastatic clear cell renal cell carcinoma confirmed by histology or cytology
- Able to provide tumor tissue samples for testing
- At least one measurable or evaluable lesion per RECIST 1.1 criteria
- Adequate bone marrow and organ function
You will not qualify if you...
- Previous or current use of HIF inhibitors
- Received chemotherapy, immunotherapy, targeted therapy, traditional Chinese anti-tumor medicine, or other clinical research drugs within 4 weeks before first study dose
- Received palliative radiotherapy within 2 weeks before first study dose
- Use of live attenuated vaccines before or expected during treatment period as specified
- Major surgery within a specified time after first dose or planned during study
- Severe gastrointestinal function abnormalities affecting drug intake or absorption
- Other active malignant tumors within 3 years or concurrent
- History of organ transplant (except corneal transplants)
- Clinically significant thrombotic or embolic event within 6 months before first dose
- Uncontrolled heart disease symptoms
- Active tuberculosis
- Moderate to severe ascites with symptoms; uncontrolled or moderate to large pleural or pericardial effusions
- Unresolved toxicities or complications from previous treatments above NCI-CTCAE grade 1
- Active hepatitis B or C
- Other factors judged by the researcher that may affect study results or require study termination
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 - From first dose until disease progression or discontinuation, up to approximately 3 years
Participants receive combinations of SHR-8068, Adebrelimab, Bevacizumab, and/or HS-10516 as anti-tumor drugs for advanced renal cell carcinoma.
Regular visits for drug administration and safety assessments as per protocol
Duration - Up to 90 days after last dose, assessments may continue up to approximately 3 years for long-term outcomes
Participants are monitored for safety and overall response after treatment ends.
Periodic visits for safety and disease status assessments
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
Y
Yuting Wang
L
Liang Hu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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