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

NCT ID: NCT07239596

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-06

Study Completion Date

2030-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Advanced Renal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-8068+ Adebrelimab + Bevacizumab

Group Type EXPERIMENTAL

SHR-8068;Adebrelimab ;Bevacizumab

Intervention Type DRUG

SHR-8068+ Adebrelimab + Bevacizumab

SHR-8068+ Adebrelimab +HS-10516

Group Type EXPERIMENTAL

SHR-8068;Adebrelimab ;HS-10516

Intervention Type DRUG

SHR-8068+ Adebrelimab +HS-10516

SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

Group Type EXPERIMENTAL

SHR-8068; Adebrelimab ; Bevacizumab ;HRS-10516

Intervention Type DRUG

SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

Interventions

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SHR-8068;Adebrelimab ;Bevacizumab

SHR-8068+ Adebrelimab + Bevacizumab

Intervention Type DRUG

SHR-8068;Adebrelimab ;HS-10516

SHR-8068+ Adebrelimab +HS-10516

Intervention Type DRUG

SHR-8068; Adebrelimab ; Bevacizumab ;HRS-10516

SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516

Intervention Type DRUG

Eligibility Criteria

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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.
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuting Wang

Role: CONTACT

+021-61053363

Liang Hu

Role: CONTACT

18036618148

Other Identifiers

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SHR-8068-207-RCC

Identifier Type: -

Identifier Source: org_study_id

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