# Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer

Source: https://onco.cc/trials/nct07262567/  
OnCo record `nct07262567` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing GFH375 in pancreatic ductal adenocarcinoma, now recruiting.

## Summary

Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer is a phase 3 interventional study registered as NCT07262567, led by Genfleet Therapeutics (Shanghai), and recruiting on the registry. Official title: A Multicenter, Open-Label, Randomised 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. Planned enrolment is 320 participants (estimated). The study started in 2025-12-04 and primary completion is expected in 2027-06. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT07262567
- Phase: 3
- Setting: 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
- Sponsor: Genfleet Therapeutics (Shanghai)
- Enrolled: 320

## Sources

- ClinicalTrials.gov NCT07262567: https://clinicaltrials.gov/study/NCT07262567

## Connected records

- cancers: [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- drugs: [GFH375](https://onco.cc/drugs/gfh375/), [Tegafur, gimeracil and oteracil (S-1)](https://onco.cc/drugs/tegafur-gimeracil-oteracil/)
- companies: [GenFleet Therapeutics](https://onco.cc/companies/genfleet/)
- roadmaps: [Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question](https://onco.cc/roadmaps/pancreatic-roadmap/)
- ideas: [RAS inhibitor combinations and sequence: pan-RAS plus G12D-selective, plus chemotherapy, and what to give after progression](https://onco.cc/ideas/idea-pdac-ras-inhibitor-combinations-and-sequencing/)

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