# ELVN-002

Source: https://onco.cc/drugs/elvn-002/  
OnCo record `elvn-002` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-1
- Last checked: 2026-11-03
- Tags: pipeline; ctgov-ingest
- Code: ELVN-002
- Modality: Oral small-molecule kinase inhibitor (irreversible)
- Mechanism: A selective, irreversible HER2 inhibitor active against HER2 mutations including exon 20 insertions.

## Sources

- Enliven Therapeutics: enliventherapeutics.com: https://www.enliventherapeutics.com/pipeline
- Enliven Therapeutics: enliventherapeutics.com: https://www.enliventherapeutics.com/pipeline
- ClinicalTrials.gov: trials of ELVN-002: https://clinicaltrials.gov/search?intr=ELVN-002

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [HER2-mutant non-small-cell lung cancer](https://onco.cc/cancers/her2-mutant-nsclc/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Enliven Therapeutics](https://onco.cc/companies/enliven-therapeutics/)
- trials: [ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer](https://onco.cc/trials/nct05650879/), [ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer](https://onco.cc/trials/nct06328738/)

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JSON: https://onco.cc/api/v1/entities/elvn-002.json