# GFH375

Source: https://onco.cc/drugs/gfh375/  
OnCo record `gfh375` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

GFH375 is an experimental small-molecule drug from Genfleet Therapeutics (Shanghai) in phase 3 trials for pancreatic ductal adenocarcinoma and non-small-cell lung cancer, aimed at KRAS.

## Summary

GFH375 is a small-molecule drug developed by Genfleet Therapeutics (Shanghai). Its target is KRAS (the sponsor names KRAS G12D). The sponsor states: GFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation, blocking KRAS-driven signalling and cancer cell growth. ClinicalTrials.gov describes the intervention as: The experimental group receives GFH375 monotherapy, QD, orally. It is the investigational product in 3 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT07262567 (Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer) and NCT07668752 (A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation), in pancreatic ductal adenocarcinoma and non-small-cell lung cancer. The largest, NCT06500676, plans to enrol 407 participants with primary completion expected 2028-07-31. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- Modality: small molecule (structure undisclosed or not yet in PubChem)
- Mechanism: GFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation, blocking KRAS-driven signalling and cancer cell growth.

## Sources

- ClinicalTrials.gov: trials of GFH375: https://clinicaltrials.gov/search?intr=GFH375

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- targets: [KRAS](https://onco.cc/targets/kras/)
- companies: [GenFleet Therapeutics](https://onco.cc/companies/genfleet/)
- trials: [A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metast](https://onco.cc/trials/nct07784374/), [A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation](https://onco.cc/trials/nct07259590/), [A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations](https://onco.cc/trials/nct06500676/), [A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation](https://onco.cc/trials/nct07668752/), [Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer](https://onco.cc/trials/nct07262567/)

---
JSON: https://onco.cc/api/v1/entities/gfh375.json