SHR-8068 with Adebrelimab and other anti-tumor drugs for advanced renal cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase Ib/II, open-label study combines the investigational agent SHR-8068 with the PD-L1 antibody Adebrelimab and other anti-tumor agents (for example bevacizumab or HS-10516) to characterize safety, tolerability, and preliminary anti-tumor activity. The Phase Ib portion uses dose-escalation to define safe dose combinations and the Phase II portion expands cohorts to measure response rates and progression endpoints. Eligible patients are adults (18–75) with histologically confirmed locally advanced unresectable or metastatic clear cell renal cell carcinoma, ECOG 0–1, measurable disease per RECIST 1.1, adequate organ function, and willing to provide tumor tissue. Key exclusions include prior HIF inhibitor exposure and recent systemic anti-cancer therapies or live attenuated vaccines within specified washout windows.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 to 75 years old (including boundary values)
2. Volunteer to participate in this clinical study and sign informed consent;
3. ECOG score 0-1;
4. Expected survival ≥3 months;
5. Patients with locally advanced unresectable or metastatic clear cell renal cell carcinoma confirmed by histology or cytology;
6. Tumor tissue samples must be provided for testing
7. There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;
8. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Have previously used or are currently using HIF inhibitors.
2. Had received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine or other clinical research drugs within 4 weeks prior to the first administration of the study; Palliative radiotherapy was received within 2 weeks before the first administration.
3. Live attenuated vaccines are used within a certain period of time before the first medication as stipulated in the plan, or it is expected that such vaccines will be needed during the treatment period.
4. Undergoing major surgical treatment within a certain period of time after the first administration of medication (excluding diagnosis) or expecting major surgical treatment during the study period.
5. There are severe gastrointestinal function abnormalities in clinical practice, which may affect the intake, transportation or absorption of drugs.
6. Suffering from other active malignant tumors within 3 years or at the same time.
7. Patients who have received organ transplants in the past (excluding corneal transplants).
8. A clinically significant thrombotic or embolic event occurred within 6 months prior to the first administration of the drug.
9. There are clinical symptoms or diseases of the heart that are not well controlled.
10. Active tuberculosis.
11. Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion.
12. The toxicity and/or complications of previous intervention measures have not been restored to the level of NCI-CTCAE≤1 or the inclusion and exclusion criteria.
13. Subjects with active hepatitis B or active hepatitis C.
14. As determined by the researcher, there are other factors that may affect the research results or lead to the forced termination of this study midway

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yuting Wang
• Email: yuting.wang@hengrui.com
• Phone: +021-61053363

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.