A Study of SHR-1802 in Patients With Advanced Solid Tumor
- Registration Number
- NCT05208177
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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 dose (RP2D) and assess objective response rate (ORR) assessed by the investigator based on RECIST v1.1 criteria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR-1802 for injection combined with Camrelizumab for Injection and Famitinib Malate Capsules SHR-1802＋camrelizumab + famitinib -
- Primary Outcome Measures
Name Time Method Dose limiting toxicity (DLT) 4 weeks ORR up to 2 years Objective Response Rate, determined according to RECIST v1.1 criteria
Recommended phase II dose (RP2D) up to 1 years
- Secondary Outcome Measures
Name Time Method PFS assessed by investigator up to 2 years Progression Free Survival, determined according to RECIST v1.1 criteria
TTR up to 2 years Time to Response，determined according to RECIST v1.1 criteria
12-month OS rate from the date of the first dose up to 2 years AEs+SAEs from the first drug administration to within 90 days for the last drug dose Adverse Events and Serious Adverse Events assessed by CTCAE v5.0
Nab up to 30 days after last dose Neutralizing Antibody of Camrelizumab for Injection and SHR-1802 for injection.
Concentration of drug in plasma n the second cycle，predose 1 hour and 6 hours post-dose；In cycle 3, cycle 4, cycle 6, cycle 8, and cycle 10，predose 1 hour（each cycle is 21 days） Plasma concentration of Famitinib malate capsule and its metabolite.
Count of T lymphocyte subsets 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection Count of CD4+ T lymphocyte subsets in peripheral blood；Count of CD8+ T lymphocyte subsets in peripheral blood.
Percentage of T lymphocyte subsets 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection Percentage of CD4+ T lymphocyte subsets in peripheral blood；Percentage of CD8+ T lymphocyte subsets in peripheral blood.
DOR up to 2 years Duration of Response, determined according to RECIST v1.1 criteria
Concentration of drug in serum 0.5 hour before the first dose up to 30 days after last dose Serum concentration of Camrelizumab for Injection and SHR-1802 for injection.
ADA up to 30 days after last dose Anti-drug antibody of Camrelizumab for Injection and SHR-1802 for injection
DCR up to 2 years Disease Control Rate, determined according to RECIST v1.1 criteria
OS (overall survival) up to 2 years From date of treatment start to any cause death or last follow-up
Trial Locations
- Locations (1)
Tianjin Medical University Cancer Institute&Hospital
🇨🇳Tianjin, Tianjin, China