{"entity":{"id":"amplify-7p","kind":"trial","name":"AMPLIFY-7P","aka":[],"tldr":"The randomised test of an off-the-shelf KRAS vaccine after pancreatic surgery. It missed its primary goal in June 2026.","summary":"Did not meet the pre-specified primary DFS endpoint in the intent-to-treat population; post-hoc landmark analyses suggested ~14% absolute DFS benefit during active dosing. Company is exploring R0-resected subgroups for phase 3. A cautionary data point for shared-antigen vaccines versus personalised approaches.","status":"negative","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT05726864","url":"https://clinicaltrials.gov/study/NCT05726864"}],"tags":[],"related":[],"cancers":["pancreatic","resectable-pdac"],"sections":[],"technologies":["shared-antigen-vaccine"],"targets":[],"drugs":["eli-002-7p"],"companies":["elicio-therapeutics"],"institutions":[],"pathways":[],"terms":["pancreatic-failed-programmes"],"trials":["eclipse","autogene-cevumeran-phase-1","nct05968326"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05726864","phase":"1/2","setting":"Adjuvant mKRAS PDAC after surgery and chemotherapy: ELI-002 7P vs observation","sponsor":"Elicio Therapeutics","result":"Primary DFS endpoint not met.","started":"2023-04-14","startedType":"actual","yearReported":2026,"enrolled":158,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival (ITT)","primary":true,"unit":"months","arms":[{"name":"ELI-002 7P","note":"Primary endpoint not met (sponsor release, 15 June 2026); ITT hazard ratio and medians not disclosed."},{"name":"Observation"}],"source":"https://elicio.com/press_releases/elicio-therapeutics-reports-results-from-phase-2-amplify-7p-study-and-outlines-refined-phase-3-development-strategy-for-eli-002-7p-in-adjuvant-pancreatic-cancer/"},{"endpoint":"Disease-free survival at 3 months (landmark)","unit":"%","arms":[{"name":"ELI-002 7P","value":90.3},{"name":"Observation","value":76.6}],"p":"0.022","source":"https://elicio.com/press_releases/elicio-therapeutics-reports-results-from-phase-2-amplify-7p-study-and-outlines-refined-phase-3-development-strategy-for-eli-002-7p-in-adjuvant-pancreatic-cancer/"},{"endpoint":"Disease-free survival, R0-resected subgroup (post hoc)","unit":"months","arms":[{"name":"ELI-002 7P","value":23.8,"note":"Post hoc analysis of 121 R0-resected patients; hypothesis-generating only."},{"name":"Observation","value":12.8}],"hr":0.65,"p":"0.048","source":"https://elicio.com/press_releases/elicio-therapeutics-reports-results-from-phase-2-amplify-7p-study-and-outlines-refined-phase-3-development-strategy-for-eli-002-7p-in-adjuvant-pancreatic-cancer/"}],"replication":"Randomised phase 2 missed its primary ITT endpoint (June 2026); the post hoc R0 subgroup signal is unreplicated and the sponsor plans a refined phase 3."},"route":"/trials/amplify-7p/","neighbours":{"cancer":[{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"resectable-pdac","kind":"cancer","name":"Resectable pancreatic ductal adenocarcinoma","route":"/cancers/resectable-pdac/"}],"technology":[{"id":"shared-antigen-vaccine","kind":"technology","name":"Off-the-shelf cancer vaccines","route":"/technologies/shared-antigen-vaccine/"}],"drug":[{"id":"eli-002-7p","kind":"drug","name":"ELI-002 7P","route":"/drugs/eli-002-7p/"}],"company":[{"id":"elicio-therapeutics","kind":"company","name":"Elicio Therapeutics","route":"/companies/elicio-therapeutics/"}],"term":[{"id":"pancreatic-failed-programmes","kind":"term","name":"Pancreatic cancer: the failed and stopped programmes and why","route":"/terms/pancreatic-failed-programmes/"}],"trial":[{"id":"nct05968326","kind":"trial","name":"A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC","route":"/trials/nct05968326/"},{"id":"autogene-cevumeran-phase-1","kind":"trial","name":"Autogene cevumeran phase 1 in resected pancreatic cancer (Memorial Sloan Kettering)","route":"/trials/autogene-cevumeran-phase-1/"},{"id":"eclipse","kind":"trial","name":"ECLIPSE (GVAX pancreas and CRS-207)","route":"/trials/eclipse/"}],"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/"}],"bottleneck":[{"id":"b-undruggable-targets","kind":"bottleneck","name":"The undruggable drivers","route":"/bottlenecks/b-undruggable-targets/"}]}}