To evaluate the safety and preliminary efficacy of HRS-4642 in combination with antineoplastic agents in subjects with advanced solid tumors with KRAS G12D mutations, and to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Treatment group Part I: HRS-4642 combined with SHR-A1921 Treatment group Part II: HRS-4642 combined with SHR-A1904 Treatment group Part II: HRS-4642 combined with AG
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGStage 1: (IB Period):DLTs
Time frame: Within 28 days of the first dose
Stage 1: (IB Period): adverse events (AEs)
Time frame: Within 28 days of the first dos,About 1 year
Phase II: (Phase II):investigator-assessed ORR
Time frame: Assessed every 6 weeks,About 1 year
Stage 1: (IB Period):Investigator-assessed objective response rate (ORR)
Time frame: Assessed every 6 weeks,About 1 year
Phase II: (Phase II):DCR
Time frame: Assessed every 6 weeks,About 1 year
Phase II: (Phase II):DoR
Time frame: Assessed every 6 weeks,About 1 year
Phase II: (Phase II):OS
Time frame: Assessed every 6 weeks+ About 1 year
Phase II: (Phase II):PFS
Time frame: Assessed every 6 weeks,About 1 year
Phase II: (Phase II):OS
Time frame: Assessed approximately once every 1 month,About 1 year
Phase II: (Phase II):Incidence and severity of AEs
Time frame: Assessed approximately once every 1 month,About 1 year
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