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

NCT07239596 | Recruiting Phase 1

• 1 other identifier: SHR-8068-207-RCC
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Progression-free survival (PFS) by investigator

  Until progression or death, assessed up to approximately 3 year

• Duration of response (DOR) by investigator assessment

  Until progression or death, assessed up to approximately 3 year

• Disease control rate (DCR) by investigator assessment

  Until progression, assessed up to approximately 3 year

• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)

  until to 90 days after the last dose，assessed up to approximately 3 years

Study Arms (3)

SHR-8068+ Adebrelimab + Bevacizumab

EXPERIMENTAL

Drug: SHR-8068；Adebrelimab ；Bevacizumab

SHR-8068+ Adebrelimab +HS-10516

EXPERIMENTAL

Drug: SHR-8068；Adebrelimab ；HS-10516

SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

EXPERIMENTAL

Drug: SHR-8068； Adebrelimab ； Bevacizumab ；HRS-10516

Interventions

SHR-8068；Adebrelimab ；Bevacizumab DRUG

SHR-8068+ Adebrelimab + Bevacizumab

SHR-8068+ Adebrelimab + Bevacizumab

SHR-8068；Adebrelimab ；HS-10516 DRUG

SHR-8068+ Adebrelimab +HS-10516

SHR-8068+ Adebrelimab +HS-10516

SHR-8068； Adebrelimab ； Bevacizumab ；HRS-10516 DRUG

SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have previously used or are currently using HIF inhibitors.
• 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.
• 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.
• 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.
• There are severe gastrointestinal function abnormalities in clinical practice, which may affect the intake, transportation or absorption of drugs.
• Suffering from other active malignant tumors within 3 years or at the same time.
• Patients who have received organ transplants in the past (excluding corneal transplants).
• A clinically significant thrombotic or embolic event occurred within 6 months prior to the first administration of the drug.
• There are clinical symptoms or diseases of the heart that are not well controlled.
• Active tuberculosis.
• Moderate and severe ascites with clinical symptoms; Uncontrolled or moderate to excessive pleural effusion and pericardial effusion.
• Subjects with active hepatitis B or active hepatitis C.
• 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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Central Study Contacts

Yuting Wang

CONTACT

+021-61053363; yuting.wang@hengrui.com

Liang Hu

CONTACT

18036618148; Liang.hu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 16, 2026

Record last verified: 2025-11

Locations

CN (1)