This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
The experimental group receives GFH375 monotherapy, QD, orally
The control group includes three treatment regimens: AG, nal-IRI + 5-FU/LV, and S-1. If participants are randomized to the control group, they will receive the treatment which is determined by the investigator.
OS
Overall Survival
Time frame: Up to approximately 2 years
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR
Time frame: Up to approximately 2 years
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors
Time frame: Up to approximately 2 years
ORR
ORR assessed by investigators and BICR
Time frame: Up to approximately 2 years
DCR
DCRassessed by investigators and BICR
Time frame: Up to approximately 2 years
DoR
DoR assessed by investigators and BICR
Time frame: Up to approximately 2 years
TTR
TTR assessed by investigators and BICR
Time frame: Up to approximately 2 years
The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Time frame: Up to approximately 2 years
EORTC QLQ-C30 Score
Changes in EORTC QLQ-C30
Time frame: Up to approximately 2 years
EORTC QLQ-PAN26 Score
Changes in EORTC QLQ-PAN26 Scores
Time frame: Up to approximately 2 years
Plasma concentrations of GFH375
Plasma concentrations of GFH375
Time frame: Up to approximately 2 years
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