This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
407
GFH375 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Phase Ia:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Time frame: 24 months
Phase Ia:The incidence of DLT events
The incidence of DLT events
Time frame: 21 days
Phase Ib:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Time frame: 24 months
Phase II:Overall response rate (ORR)
For NSCLC cohort: Assessed by BICR according to RECIST 1.1;For other cohorts: Assessed by investigators according to RECIST 1.1;
Time frame: 24 months
Plasma concentrations
Plasma concentrations and PK parameters of GFH375
Time frame: up to 21 days
Efficacy endpoints
Duration of response (DoR)
Time frame: 24 months
Efficacy endpoints
Disease control rate (DCR)
Time frame: 24 months
Efficacy endpoints
Progression free survival (PFS)
Time frame: 24 months
Efficacy endpoints
Overall survival (OS)
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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