NCT07239596 Phase Ib/II Clinical Study of SHR-8068 Combined Anti-tumor Drugs in the Treatment of Advanced Renal Cell Carcinom
| NCT ID | NCT07239596 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Advanced Renal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 92 participants in total. It began in 2026-01-06 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluated the safety and efficacy of SHR-8068 in combination anti-tumor drugs in the treatment of advanced renal cell carcinoma
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07239596 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Renal Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07239596 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07239596 currently recruiting?
Yes, NCT07239596 is actively recruiting participants. Contact the research team at yuting.wang@hengrui.com for enrollment information.
Where is the NCT07239596 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07239596 clinical trial?
NCT07239596 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 92 participants.