This is a multicenter, open-label, phase II study to explore the efficacy, safety/tolerability and pharmacokinetics (PK) of GFH375 in in Patients with Previously Treated KRAS G12D Mutant Metastatic Pancreatic Cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
GFH375 will be administered at the 600mg QD, orally, until disease progression or intolerable toxicity.
Overall response rate (ORR)
ORR assessed by Blinded Independent Central Review
Time frame: 24 months
ORR
ORR assessed by investigators
Time frame: 24 months
DCR
Disease control rate (DCR)
Time frame: 24 months
DoR
Duration of Response (DoR)
Time frame: 24 months
TTR
Time to Response(TTR)
Time frame: 24 months
PFS
Progression Free Survival (PFS)
Time frame: 24 months
The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Time frame: 24 months
Plasma concentrations of GFH375
Plasma concentrations of GFH375
Time frame: 6 months
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