The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
administrated per dose level in which the patients are assigned
administrated per dose level in which the patients are assigned
administrated per dose level in which the patients are assigned
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Phase IB: Safety endpoints: adverse events (AEs).
Assess safety and tolerability by way of adverse events (CTCAE v5.0).
Time frame: 24 months
Phase IB: Maximum tolerated dose (MTD)
Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of treatment.
Time frame: From Day 1 to Day 21
Phase IB:Recommended phase 2 dose (RP2D)
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.
Time frame: 24 months
Phase II: Overall response rate (ORR).
Evaluated by RECIST v1.1.
Time frame: 24 months.
Efficacy endpoints: Overall response rate (ORR).
Evaluated by RECIST v1.1.
Time frame: 24 months
Efficacy endpoints: Duration of response (DoR).
Evaluated by RECIST v1.1.
Time frame: 24 months
Efficacy endpoints: Disease control rate (DCR).
Evaluated by RECIST v1.1.
Time frame: 24 months
Efficacy endpoints: Progression free survival (PFS).
Evaluated by RECIST v1.1.
Time frame: 24 months
Efficacy endpoints: overall survival (OS).
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administered as prescribed by the investigator.
administrated per dose level in which the patients are assigned
Evaluated by RECIST v1.1.
Time frame: 24 months