Advanced Renal Cell Carcinoma
Conditions
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
Interventions
DRUGSHR-8068；Adebrelimab ；Bevacizumab
SHR-8068+ Adebrelimab + Bevacizumab
DRUGSHR-8068 ; SHR-4610
SHR-8068+ SHR-4610
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | 21days after the first administration of each subject | DLT defined as the Incidence and severity of adverse events |
| Overall response rate(ORR) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) by investigator | 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 |
| Duration of response (DOR) by investigator assessment | 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 |
| Disease control rate (DCR) by investigator assessment | 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 |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | 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 |
Countries
China
Contacts
CONTACTYuting Wang
CONTACTLiang Hu
Outcome results
None listed