Status:
TERMINATED
A Study of SHR-1802 in Patients With Advanced Solid Tumor
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To assess the safety and tolerability of SHR-1802 combined with camrelizumab and famitinib in subjects with advanced solid tumor and to determine the dose-limiting toxicity (DLT)，recommended phase II ...
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Has a life expectancy≥ 3 months;
- At least one measurable lesion according to RECIST v1.1;
- Pathologically confirmed advanced solid tumor;
- Adequate bone marrow reserve and organ function.
Exclusion
- Have received prior therapy with camrelizumab, and famitinib;
- Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the treatment;
- Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the treatment;
- Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
- Have known history of arterial/venous thrombosis within 6 months prior to the first dose of the treatment, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism;
- Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the treatment;
- Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.
Key Trial Info
Start Date :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05208177
Start Date
April 22 2022
End Date
August 18 2023
Last Update
August 22 2025
Active Locations (1)
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1
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China, 300202