{"entity":{"id":"nct07621718","kind":"trial","name":"Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-muta","aka":["RASolute 305"],"tldr":"A phase 3 trial of Zoldonrasib, CAPOX, FLOT in pancreatic ductal adenocarcinoma, run by Revolution Medicines, Inc., now recruiting.","summary":"Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 ) is a phase 3 interventional study registered as NCT07621718 by Revolution Medicines, Inc., with 670 participants planned, started 2026-05-22 and due to reach its primary completion in 2028-12-30. Interventions recorded: Zoldonrasib, Placebo, Oxaliplatin, Leucovorin (Calcium Folinate), 5-Fluorouracil. Conditions listed: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma. No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT07621718","url":"https://clinicaltrials.gov/study/NCT07621718"}],"tags":["ctgov-ingest"],"related":[],"cancers":["pancreatic","metastatic-pdac"],"sections":[],"technologies":["cytotoxic-chemotherapy","kras-inhibitors"],"targets":[],"drugs":["zoldonrasib","capox","flot","leucovorin","folfiri","gemcitabine"],"companies":["revolution-medicines"],"institutions":[],"pathways":[],"terms":["pancreatic-trials-open-today","kras-mutation-subtypes"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["RASolute 305 (registry, 24 September 2026): phase 3, double-blind, investigator's choice of modified FOLFIRINOX or gemcitabine plus nab-paclitaxel with or without zoldonrasib as first-line treatment for metastatic KRAS G12D-mutated pancreatic adenocarcinoma; 670 participants (estimated), recruiting, started 22 May 2026, primary completion December 2028; United States sites only so far."],"nct":"NCT07621718","phase":"3","setting":"RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma","sponsor":"Revolution Medicines, Inc.","started":"2026-05-22","startedType":"actual","enrolled":670,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07621718/","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/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"kras-inhibitors","kind":"technology","name":"KRAS & RAS inhibitors","route":"/technologies/kras-inhibitors/"}],"drug":[{"id":"capox","kind":"drug","name":"CAPOX (capecitabine, oxaliplatin)","route":"/drugs/capox/"},{"id":"flot","kind":"drug","name":"FLOT (5-FU, leucovorin, oxaliplatin, docetaxel)","route":"/drugs/flot/"},{"id":"folfiri","kind":"drug","name":"FOLFIRI (5-FU, leucovorin, irinotecan)","route":"/drugs/folfiri/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"zoldonrasib","kind":"drug","name":"Zoldonrasib","route":"/drugs/zoldonrasib/"}],"company":[{"id":"revolution-medicines","kind":"company","name":"Revolution Medicines","route":"/companies/revolution-medicines/"}],"term":[{"id":"kras-mutation-subtypes","kind":"term","name":"KRAS mutation subtypes (G12C, G12D, G12V)","route":"/terms/kras-mutation-subtypes/"},{"id":"pancreatic-trials-open-today","kind":"term","name":"Pancreatic cancer trials open today (registry snapshot and UK sites)","route":"/terms/pancreatic-trials-open-today/"}],"idea":[{"id":"idea-bio1-pan-ras-covalent-g12d","kind":"idea","name":"Covalent chemistry for the RAS mutations that still have no drug","route":"/ideas/idea-bio1-pan-ras-covalent-g12d/"},{"id":"idea-shared-kras-vaccine-adjuvant","kind":"idea","name":"Off-the-shelf KRAS vaccines after pancreatic cancer surgery","route":"/ideas/idea-shared-kras-vaccine-adjuvant/"}]}}