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

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

This trial will test whether adding SHR-8068 to Adebrelimab (with or without other anti-cancer drugs) helps people with advanced clear cell renal cell carcinoma.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 139 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, Adebrelimab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07239596 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed locally advanced unresectable or metastatic clear-cell renal cell carcinoma, ECOG performance status 0–1, at least one measurable lesion, adequate organ and marrow function, and able to provide tumor tissue are ideal candidates.

Not a fit: Patients who have recently received systemic anti-cancer therapy, received live attenuated vaccines within the prohibited window, previously used HIF inhibitors, have non–clear-cell histology, or have poor performance status are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, the combination could improve tumor control or delay progression for some people with advanced clear cell renal cell carcinoma and offer a new treatment option.

How similar studies have performed: Combinations of immune checkpoint inhibitors with VEGF-targeting or other targeted agents have shown benefit in renal cell carcinoma, but SHR-8068 itself is a novel agent and its combinations remain early and not yet proven.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yuting Wang

Conditions Advanced Renal Cell Carcinoma