Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Other Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom

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 study evaluated the safety and efficacy of SHR-8068 in combination with Adebrelimab and other anti-tumor drugs in the treatment of advanced renal cell carcinoma

Study Overview

• Status: Recruiting
• Conditions: Advanced Renal Cell Carcinoma
• Intervention / Treatment: Drug: SHR-8068；Adebrelimab ；Bevacizumab; Drug: SHR-8068；Adebrelimab ；HS-10516; Drug: SHR-8068； Adebrelimab ； Bevacizumab ；HRS-10516

• Study Type: Interventional
• Enrollment (Estimated): 139
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Liang Hu; Phone Number: 18036618148; Email: Liang.hu@hengrui.com
• Study Contact Backup: Name: Yuting Wang; Phone Number: +021-61053363; Email: yuting.wang@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Principal Investigator: Jun Guo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-8068+ Adebrelimab + Bevacizumab	Drug: SHR-8068；Adebrelimab ；Bevacizumab; SHR-8068+ Adebrelimab + Bevacizumab
Experimental: SHR-8068+ Adebrelimab +HS-10516	Drug: SHR-8068；Adebrelimab ；HS-10516; SHR-8068+ Adebrelimab +HS-10516
Experimental: SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516	Drug: SHR-8068； Adebrelimab ； Bevacizumab ；HRS-10516; SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT)	DLT defined as the Incidence and severity of adverse events	21days after the first administration of each subject
Overall response rate(ORR)	Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator	from first dose to disease progression or death, whichever comes first, up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)	Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	until to 90 days after the last dose，assessed up to approximately 3 years
Progression-free survival (PFS) by investigator	Defined as time from first administration until progression or death as assessed by the investigator	Until progression or death, assessed up to approximately 3 year
Duration of response (DOR) by investigator assessment	Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator	Until progression or death, assessed up to approximately 3 year
Disease control rate (DCR) by investigator assessment	Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator	Until progression, assessed up to approximately 3 year

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SHR-8068-207-RCC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No