This is a first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
252
All participants receive SHR-A2102 alone.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose Limited Toxicity (DLT)
Time frame: 21 Days (first cycle)
Maximum tolerable dose (MTD)
Time frame: 21 Days (first cycle)
Recommended dose for phase II (RP2D)
Time frame: Up to 8 months
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-A2102
Time frame: 30 days after last dose
Maximum observed plasma concentration (Cmax) of SHR-A2102
Time frame: 30 days after last dose
Time of maximum observed plasma concentration (Tmax) of SHR-A2102
Time frame: 30 days after last dose
Immunogenicity Analysis
ADA
Time frame: 30 days after last dose
ORR
Objective Response Rate
Time frame: 24 months
DCR
Disease Control Rate
Time frame: 24 months
DoR
Duration of Response
Time frame: 24 months
PFS
Progression-Free-Survival
Time frame: 24 months
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OS
Overall survival
Time frame: 24 months