This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Dose Escalation: SHR-3276 will be administered intravenously. 4 dose levels are preset. Dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. Indication Expansion: Indications will be selected to evaluate preliminary efficacy.
The Second Affiliated Hospital of PLA Army Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGIncidence and severity of adverse events
Time frame: up to 3 years
MTD
Time frame: up to 6 months
RP2D
Time frame: up to 1 year
Time to maximum concentration (Tmax)
Time frame: up to 3 years
Maximum concentration (Cmax)
Time frame: up to 3 years
Receptor Occupancy(OR) of SHR-3276
Time frame: up to 3 years
Anti-drug antibody (ADA) of SHR-3276
Time frame: up to 3 years
Objective response rate (ORR)
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Duration of response (DoR)
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Disease control rate (DCR)
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
Progression free survival(PFS)
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years
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Overall survival (OS)
Time frame: From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years