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Recruiting 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

Phase I / Phase II Interventional Advanced Renal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-8068；Adebrelimab ；Bevacizumab, SHR-8068；Adebrelimab ；HS-10516, SHR-8068； Adebrelimab ； Bevacizumab ；HRS-10516.
Who it may be relevant to
Registry conditions: Advanced Renal Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Interventions

  • Drug SHR-8068；Adebrelimab ；Bevacizumab
    SHR-8068+ Adebrelimab + Bevacizumab
  • Drug SHR-8068；Adebrelimab ；HS-10516
    SHR-8068+ Adebrelimab +HS-10516
  • Drug SHR-8068； Adebrelimab ； Bevacizumab ；HRS-10516
    SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: 21days after the first administration of each subject]
  • Overall response rate(ORR) [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
Secondary outcome measures (4)
  • Progression-free survival (PFS) by investigator [Time frame: Until progression or death, assessed up to approximately 3 year]
  • Duration of response (DOR) by investigator assessment [Time frame: Until progression or death, assessed up to approximately 3 year]
  • Disease control rate (DCR) by investigator assessment [Time frame: Until progression, assessed up to approximately 3 year]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Cancer Hospital — Beijing

Identifiers

NCT: NCT07239596 · SHR-8068-207-RCC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗