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

Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Other Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom (NCT07239596) is a Phase 1 / Phase 2 interventional studying Advanced Renal Cell Carcinoma, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Renal Cell Carcinoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 139 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Renal Cell Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18 to 75 years old (including boundary values) 2. Volunteer to participate in this clinical study and sign willing to sign a consent form; 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07239596), the sponsor (Suzhou Suncadia Biopharmaceuticals Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07239596 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07239596?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07239596?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07239596. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07239596. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.