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NCT Number: NCT07239596

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location status: Recruiting

Location contact

Jun Guo

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.
  • 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.
  • 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

Treatment and study plan

SHR-8068;Adebrelimab ;Bevacizumab

Drug

SHR-8068+ Adebrelimab + Bevacizumab

SHR-8068;Adebrelimab ;HS-10516

Drug

SHR-8068+ Adebrelimab +HS-10516

SHR-8068; Adebrelimab ; Bevacizumab ;HRS-10516

Drug

SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Time frame: 21days after the first administration of each subject

    DLT defined as the Incidence and severity of adverse events

  2. Overall response rate(ORR)

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

    Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator

Secondary outcomes

  1. Progression-free survival (PFS) by investigator

    Time frame: Until progression or death, assessed up to approximately 3 year

    Defined as time from first administration until progression or death as assessed by the investigator

  2. Duration of response (DOR) by investigator assessment

    Time frame: Until progression or death, assessed up to approximately 3 year

    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

  3. Disease control rate (DCR) by investigator assessment

    Time frame: Until progression, assessed up to approximately 3 year

    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

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

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

    Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Hu

CONTACT

[email protected]

18036618148

Yuting Wang

CONTACT

[email protected]

+021-61053363

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Nov 20, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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