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

March 12, 2026 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity (DLT)
Time Frame: 21days after the first administration of each subject
DLT defined as the Incidence and severity of adverse events
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
until to 90 days after the last dose，assessed up to approximately 3 years
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
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
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
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
Until progression, assessed up to approximately 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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