drugset / Trial / NCT07262567
Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-12-04
- Primary completion
- 2027-06
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Calcium folinate | Unknown | — | — |
| Subject | GFH375 | Small molecule | — | Oral |
| Comparator | Gemcitabine | Small molecule | — | — |
| Comparator | Irinotecan | Small molecule | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |
| Comparator | S-1 | Small molecule | — | — |
| Comparator | fluorouracil | Small molecule | — | — |