RecruitingPhase 1Phase 2NCT07239596

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


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

139 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria13

  • 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

Interventions

DRUGSHR-8068;Adebrelimab ;Bevacizumab

SHR-8068+ Adebrelimab + Bevacizumab

DRUGSHR-8068;Adebrelimab ;HS-10516

SHR-8068+ Adebrelimab +HS-10516

DRUGSHR-8068; Adebrelimab ; Bevacizumab ;HRS-10516

SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT07239596


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