ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
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Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
198estimated
Sites
39
Countries
Australia, France, Italy +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-03-20 | actual | When the study began enrolling |
| Primary completion | Jul 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2022-12-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- HER2 Mutant Non-small Cell Lung Cancer
- HER2-positive Metastatic Breast Cancer
- HER2 Gene Mutation
- HER2 Amplification
Interventions
- Drug: ELVN-002
- Drug: Fam-Trastuzumab Deruxtecan-Nxki — also filed as Enhertu, T-DXd
- Drug: Trastuzumab emtansine — also filed as Kadcyla, T-DM1
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose limiting toxicities in Phase 1a monotherapy
measured 21 days
Incidence of adverse events in Phase 1a monotherapy
measured 24 months
incidence of laboratory abnormalities in Phase 1a monotherapy
measured 24 months
incidence of ECG abnormalities in Phase 1a monotherapy
measured 24 months
incidence of dose limiting toxicities in Phase 1a combination with fam-trastuzumab deruxtecan (T-DXd)
measured 42 days
Incidence of adverse events in Phase 1a combination with T-DXd
measured 24 months
incidence of laboratory abnormalities in Phase 1a combination with T-DXd
measured 24 months
incidence of ECG abnormalities in Phase 1a combination with T-DXd
measured 24 months
incidence of dose limiting toxicities in Phase 1a combination with trastuzumab emantasine (T-DM1)
measured 42 days
Incidence of adverse events in Phase 1a combination with T-DM1
measured 24 months
incidence of laboratory abnormalities in Phase 1a combination with T-DM1
measured 24 months
incidence of ECG abnormalities in Phase 1a combination with T-DM1
measured 24 months
Incidence of adverse events in Phase 1b monotherapy
measured 24 months
incidence of laboratory abnormalities in Phase 1b monotherapy
measured 24 months
incidence of ECG abnormalities in Phase 1b monotherapy
measured 24 months
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