{"entity":{"id":"gfh375","kind":"drug","name":"GFH375","aka":[],"tldr":"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.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of GFH375","url":"https://clinicaltrials.gov/search?intr=GFH375"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","nsclc"],"sections":[],"technologies":[],"targets":["kras"],"drugs":[],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07262567","nct07668752","nct07259590","nct06500676"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gfh375/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"target":[{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"}],"company":[{"id":"genfleet","kind":"company","name":"GenFleet Therapeutics","route":"/companies/genfleet/"}],"trial":[{"id":"nct07784374","kind":"trial","name":"A Phase II Study of GFH375 Combined With GFS202A or GFH276 Versus GFH375 Monotherapy in Patients With Previously Treated Locally Advanced Unresectable or Metast","route":"/trials/nct07784374/"},{"id":"nct07259590","kind":"trial","name":"A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation","route":"/trials/nct07259590/"},{"id":"nct06500676","kind":"trial","name":"A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations","route":"/trials/nct06500676/"},{"id":"nct07668752","kind":"trial","name":"A Study to Evaluate GFH375 Versus Docetaxel in Participants With Non-Small Cell Lung Cancer With KRAS G12D Mutation","route":"/trials/nct07668752/"},{"id":"nct07262567","kind":"trial","name":"Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer","route":"/trials/nct07262567/"}]}}