This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Cohort study
Icon Cancer Centre
Brisbane, Queensland, Australia
Linear clinical research
Perth, Western Australia, Australia
Scientia Clinical research
Sydney, Australia
Liverpool Hospital
Sydney, Australia
Adverse events
Number of subjects with adverse events (AEs)
Time frame: Screening up to study completion, an average of 2 years
Number of participants experiencing Dose-Limiting Toxicities (DLTs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
Time frame: Up to 42 days
PK of SHR-2002 + SHR-1316
To check Maximum concentration (Cmax)
Time frame: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
PK of SHR-2002 + SHR-1316
To check AUC last
Time frame: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
Immunogenicity of SHR-2002 + SHR-1316
ADA of SHR-2002 + SHR-1316
Time frame: Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years
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