This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
be administered via intravenous (IV) infusion
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGIncidence and severity of adverse events (AEs)
Time frame: From Day 1 to 90 days after last dose
Maximum tolerated dose (MTD)
Time frame: From Day 1 to 21 days after first dose
Dose Limiting Toxicities (DLT)
Time frame: From Day 1 to 21 days after first dose
Recommended Phase 2 dose (RP2D)
Time frame: From Day 1 to 90 days after last dose
PK parameters of SHR-4602 for Injection: Cmax
Time frame: the date of first dose to 30 days after last dose
PK parameters of SHR-4602 for Injection: AUC0-t
Time frame: the date of first dose to 30 days after last dose
PK parameters of SHR-4602 for Injection: Tmax
Time frame: the date of first dose to 30 days after last dose
PK parameters of SHR-4602 for Injection: T1/2
Time frame: the date of first dose to 30 days after last dose
ADA
Anti-drug antibody, Immunogenicity of SHR-4602 for Injection
Time frame: the date of first dose up to 90 days after last dose
ORR
Objective Response Rate, Efficacy endpoints of SHR-4602 for Injection,As assessed by RECIST v1.1
Time frame: the date of first dose up to 90 days after last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DCR
Disease control rate, Efficacy endpoints of SHR-4602 for Injection,As assessed by RECIST v1.1
Time frame: the date of first dose up to 90 days after last dose
DOR
Duration of response, Efficacy endpoints of SHR-4602 for Injection,As assessed by RECIST v1.1
Time frame: the date of first dose up to 90 days after last dose
PFS
Progression Free Survival, Efficacy endpoints of SHR-4602 for Injection,As assessed by RECIST v1.1
Time frame: the date of first dose up to 90 days after last dose