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Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Summary
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.
Official title: A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety/Tolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2025-12
Completion Date
2028-06
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
GFH375
The experimental group receives GFH375 monotherapy, QD, orally
Chemotherapy
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.