Advanced Renal Cell CarcinomaPhase 1/2NCT07239596
Phase Ib/II Clinical Study of SHR-8068 Combined Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom
A Phase 1/2 study testing SHR-8068；Adebrelimab ；Bevacizumab and SHR-8068 ; SHR-4610 in people with Advanced Renal Cell Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This study evaluated the safety and efficacy of SHR-8068 in combination anti-tumor drugs in the treatment of advanced renal cell carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- SHR-8068；Adebrelimab ；Bevacizumab and SHR-8068 ; SHR-4610
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2026to Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo
About this study
Official title: An Open, Multicenter Phase Ib/II Clinical Study of SHR-8068 in Combination Anti-tumor Drugs for the Treatment of Advanced Renal Cell Carcinoma
This study evaluated the safety and efficacy of SHR-8068 in combination anti-tumor drugs in the treatment of advanced renal cell carcinoma
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- SHR-8068；Adebrelimab ；Bevacizumab, SHR-8068 ; SHR-4610
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-8068；Adebrelimab ；BevacizumabDrug
SHR-8068+ Adebrelimab + Bevacizumab
SHR-8068 ; SHR-4610Drug
SHR-8068+ SHR-4610
| Study group | Role | What they receive |
|---|---|---|
| SHR-8068+ Adebrelimab + Bevacizumab | Experimental | Not described Receives: Drug: SHR-8068；Adebrelimab ；Bevacizumab |
| SHR-8068+ SHR-4610 | Experimental | Not described Receives: Drug: SHR-8068 ; SHR-4610 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
DLT defined as the Incidence and severity of adverse events
Measured: 21days after the first administration of each subject
Overall response rate(ORR)
Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator
Measured: from first dose to disease progression or death, whichever comes first, up to 3 years
Secondary outcomes (4)
Progression-free survival (PFS) by investigator
Defined as time from first administration until progression or death as assessed by the investigator
Measured: Until progression or death, assessed up to approximately 3 year
Duration of response (DOR) by investigator assessment
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
Measured: Until progression or death, assessed up to approximately 3 year
Disease control rate (DCR) by investigator assessment
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
Measured: Until progression, assessed up to approximately 3 year
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: until to 90 days after the last dose，assessed up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start6 Jan 2026
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239596
- Sponsor's protocol ID
- SHR-8068-207-RCC
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter Phase Ib/II Clinical Study of SHR-8068 in Combination Anti-tumor Drugs for the Treatment of Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07239596
- Acronym / sponsor ID
- SHR-8068-207-RCC
- Conditions
- Advanced Renal Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the safety and efficacy of SHR-8068 in combination anti-tumor drugs in the treatment of advanced renal cell carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-8068+ Adebrelimab + Bevacizumab | Experimental | Drug: SHR-8068；Adebrelimab ；Bevacizumab |
| SHR-8068+ SHR-4610 | Experimental | Drug: SHR-8068 ; SHR-4610 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-8068；Adebrelimab ；BevacizumabSHR-8068+ Adebrelimab + Bevacizumab | Drug | SHR-8068+ Adebrelimab + Bevacizumab |
| SHR-8068 ; SHR-4610SHR-8068+ SHR-4610 | Drug | SHR-8068+ SHR-4610 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 21days after the first administration of each subject
DLT defined as the Incidence and severity of adverse events
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-8068；Adebrelimab ；Bevacizumab and SHR-8068 ; SHR-4610 in people with Advanced Renal Cell Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuting Wang (+021-61053363, yuting.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 21days after the first administration of each subject). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.