{"entity":{"id":"nct07262567","kind":"trial","name":"Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer","aka":[],"tldr":"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.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07262567","url":"https://clinicaltrials.gov/study/NCT07262567"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":[],"targets":[],"drugs":["gfh375","tegafur-gimeracil-oteracil"],"companies":["genfleet"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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)","participation":[{"nct":"NCT07262567","source":"https://clinicaltrials.gov/study/NCT07262567","fetchedAt":"2026-10-07T16:55:36.272Z","studySha256":"d8e83c361aac2d320ea9aae376acbb639ad94b1c8894035ec1d0c9d8cd045435","overallStatus":"RECRUITING","lastUpdatePosted":"2026-08-14","leadSponsor":"Genfleet Therapeutics (Shanghai) Inc.","collaboratorCount":0,"minimumAge":"18 Years","maximumAge":"80 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":320,"enrolmentType":"ESTIMATED","siteCount":1,"recruitingSiteCount":1,"countries":["China"]}],"started":"2025-12-04","startedType":"actual","enrolled":320,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07262567/","neighbours":{"cancer":[{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"drug":[{"id":"gfh375","kind":"drug","name":"GFH375","route":"/drugs/gfh375/"},{"id":"tegafur-gimeracil-oteracil","kind":"drug","name":"Tegafur, gimeracil and oteracil (S-1)","route":"/drugs/tegafur-gimeracil-oteracil/"}],"company":[{"id":"genfleet","kind":"company","name":"GenFleet Therapeutics","route":"/companies/genfleet/"}],"roadmap":[{"id":"pancreatic-roadmap","kind":"roadmap","name":"Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question","route":"/roadmaps/pancreatic-roadmap/"}],"idea":[{"id":"idea-pdac-ras-inhibitor-combinations-and-sequencing","kind":"idea","name":"RAS inhibitor combinations and sequence: pan-RAS plus G12D-selective, plus chemotherapy, and what to give after progression","route":"/ideas/idea-pdac-ras-inhibitor-combinations-and-sequencing/"}]}}