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.
Voluntarily participate in the study and sign the informed consent form.
Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.
Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.
Have received at least one prior standard systemic therapy.
Other malignant tumors that progressed or required treatment within 3 years prior to randomization.
With active central nervous system (CNS) metastasis.
Previous receipt of therapy targeted for KRAS G12D or pan-RAS/KRAS.
Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.
Parallel
GFH375
DrugThe experimental group receives GFH375 monotherapy, QD, orally
Chemotherapy
DrugThe 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
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by BICR
PFS
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors
ORR
ORR assessed by investigators and BICR
DCR
DCRassessed by investigators and BICR
DoR
DoR assessed by investigators and BICR
Click on the lead sponsor to view all of their trials.