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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
SHR-1802 for injection,q3w; Camrelizumab for injection, q3w; Famitinib malate capsules, qd.
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, China
Dose limiting toxicity (DLT)
Time frame: 4 weeks
Recommended phase II dose (RP2D)
Time frame: up to 1 years
ORR
Objective Response Rate, determined according to RECIST v1.1 criteria
Time frame: up to 2 years
DOR
Duration of Response, determined according to RECIST v1.1 criteria
Time frame: up to 2 years
DCR
Disease Control Rate, determined according to RECIST v1.1 criteria
Time frame: up to 2 years
PFS assessed by investigator
Progression Free Survival, determined according to RECIST v1.1 criteria
Time frame: up to 2 years
TTR
Time to Response,determined according to RECIST v1.1 criteria
Time frame: up to 2 years
OS (overall survival)
From date of treatment start to any cause death or last follow-up
Time frame: up to 2 years
12-month OS rate
Time frame: from the date of the first dose up to 2 years
AEs+SAEs
Adverse Events and Serious Adverse Events assessed by CTCAE v5.0
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Time frame: from the first drug administration to within 90 days for the last drug dose
Concentration of drug in serum
Serum concentration of Camrelizumab for Injection and SHR-1802 for injection.
Time frame: 0.5 hour before the first dose up to 30 days after last dose
Concentration of drug in plasma
Plasma concentration of Famitinib malate capsule and its metabolite.
Time frame: 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)
Count of T lymphocyte subsets
Count of CD4+ T lymphocyte subsets in peripheral blood;Count of CD8+ T lymphocyte subsets in peripheral blood.
Time frame: 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
Percentage of T lymphocyte subsets
Percentage of CD4+ T lymphocyte subsets in peripheral blood;Percentage of CD8+ T lymphocyte subsets in peripheral blood.
Time frame: 30 minutes before the first dose of SHR-1802, the 4th and 8th days after the first injection
ADA
Anti-drug antibody of Camrelizumab for Injection and SHR-1802 for injection
Time frame: up to 30 days after last dose
Nab
Neutralizing Antibody of Camrelizumab for Injection and SHR-1802 for injection.
Time frame: up to 30 days after last dose