This is an, open-label, multi-center, three-part phase I trial to evaluate the safety, pharmacokinetics and immunogenicity of SHR-1909 and preliminary anti-tumor efficacy of SHR-1909 in advanced malignant cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
SHR-1909 for intravenous injection;Strength:6ml:0.3g/vial. Dose escalation (non randomized, 6 dose-levels); Dose-expansion and efficacy-expansion(non-randomized,1-3 dose-level(s)).
Jilin Cancer Hospital
Changchun, Jilin, China
MTD of SHR-1909
Maximum tolerated dose (MTD) based on dose-limiting toxicities (DLTs)
Time frame: From Day 1 to 4 weeks
RP2D of SHR-1909
Recommended Phase 2 Dose(RP2D) of SHR-1909 will be determined during the dose-escalation and dose-expansion parts of the study. RP2D will be determined using available safety, pharmacokinetics and pharmacodynamics data.
Time frame: From Day 1 to 90 days after last dose
Adverse Events
Adverse Events documented by CTCAE 5.0
Time frame: 90 days after the last dose
Objective Response Rate (ORR)
Baseline to documented disease progression or study discontinuation
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
From Day 1 to Radiographic Progression or Death Due to Any Cause
Time frame: Up to approximately 2 years
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