This trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
SHR-8203 Injection Dose 1/ Dose 2/ Dose 3/ Dose 4
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
The number of subjects with dose-limiting toxicity (DLT)
Time frame: From first dose of study treatment until the end of Cycle 1(up to 21 days)
Incidence and severity of AEs
Time frame: From the first visit to the end of the safety follow-up period (1 year)
Maximum Tolerated Dose
Time frame: During the DLT observation period, the dose level at which the estimated toxicity probability was closest to the target toxicity probability (i.e., 0.3)(up to 21 days)
Determination of Recommended Phase II dose (RP2D)
Time frame: After dose optimization, sufficient safety, tolerability, PK and preliminary efficacy results were obtained, and the dose selected for the subsequent indication expansion stage was confirmed by SRC discussion (1 year).
Objective Response Rate (ORR)
Time frame: From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
Duration of Response (DoR)
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
Disease Control Rate (DCR)
Time frame: From time of first dose of SHR-8203 until the date of objective disease progression or death (1 year)
Progression free Survival (PFS)
Progression-free survival is defined as the time from the start of treatment until the date of objective disease progression or death.
Time frame: From time of first dose of objective disease progression until the date of objective disease progression or death (1 year)
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Overall Survival (OS)
The time until death due to any cause.
Time frame: From time of first dose of objective disease progression until the date of death (2 years)