The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 combined with Sintilimab in patients with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
IBI325 + sintilimab combination does-escalation Patients will receive IBI325 monotherapy on Cycle 1 Day 1 ,and then receive IBI325 and sintilimab combination until progressive disease, intolerability, or other reasons leading to treatment discontinuation
Shandong Province Cancer Hospital
Jinan, Shandong, China
Number of patients with DLT
Number of patients who experienced a dose-limiting toxicity within the first 42 days after the first dose
Time frame: 42 days post first dose
Number of patients with treatment related AEs
Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose
Time frame: Up to 90 days post last dose
Number of patients with response
Number of patients with response per RECIST 1.1
Time frame: Every 6 weeks until progressive disease or up to 24 months after treatment, whichever came first
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