{"entity":{"id":"elvn-002","kind":"drug","name":"ELVN-002","aka":[],"tldr":"ELVN-002 is an experimental oral small-molecule kinase inhibitor from Enliven Therapeutics, in phase 1 trials for HER2-mutant non-small cell lung cancer, HER2-positive breast cancer and HER2-positive gastric and colorectal cancer; development is paused.","summary":"ELVN-002 is an oral small-molecule kinase inhibitor (irreversible) from Enliven Therapeutics. A selective, irreversible HER2 inhibitor active against HER2 mutations including exon 20 insertions. Its furthest stage is phase 1, for HER2-mutant non-small cell lung cancer, HER2-positive breast cancer and HER2-positive gastric and colorectal cancer. ClinicalTrials.gov registers it in 2 studies linked below. Company: \"In May 2025, we made the decision to explore strategic alternatives for ELVN-002 so that we could prioritize relcobatinib.\" Both phase 1 trials active, not recruiting. Whether it works in people has not been established unless a trial below reports it.","status":"phase-1","asOf":"2026-11-03","links":[{"label":"Enliven Therapeutics: enliventherapeutics.com","url":"https://www.enliventherapeutics.com/pipeline"},{"label":"Enliven Therapeutics: enliventherapeutics.com","url":"https://www.enliventherapeutics.com/pipeline"},{"label":"ClinicalTrials.gov: trials of ELVN-002","url":"https://clinicaltrials.gov/search?intr=ELVN-002"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["her2-mutant-nsclc","breast-her2-positive","colorectal"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":["enliven-therapeutics"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05650879","nct06328738"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo gap audit, class 5 (company pipeline pages and ClinicalTrials.gov v2)","editedOn":"2026-11-03"},"code":"ELVN-002","modality":"Oral small-molecule kinase inhibitor (irreversible)","mechanism":"A selective, irreversible HER2 inhibitor active against HER2 mutations including exon 20 insertions.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/elvn-002/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-mutant-nsclc/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"enliven-therapeutics","kind":"company","name":"Enliven Therapeutics","route":"/companies/enliven-therapeutics/"}],"trial":[{"id":"nct05650879","kind":"trial","name":"ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer","route":"/trials/nct05650879/"},{"id":"nct06328738","kind":"trial","name":"ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer","route":"/trials/nct06328738/"}]}}