ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
← catalyst calendarNCT06328738 · readout ≤ 165 d
Sponsored by Enliven Therapeutics (industry) · ELVN — their whole pipeline →.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
275estimated
Sites
31
Countries
Belgium, 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 | 2024-05-30 | actual | When the study began enrolling |
| Primary completion | Jan 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-03-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- HER2-positive Breast Cancer
- HER2-positive Gastric Cancer
- HER2 Positive Solid Tumors
- HER2 Amplification
- Colorectal Cancer
Interventions
- Drug: ELVN-002
- Drug: Trastuzumab
- Drug: 5-Fluorouracil
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: Eribulin
- Drug: paclitaxel
- Drug: Leucovorin
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose limiting toxicities (DLTs; Phase 1a only)
measured 21 days
Incidence of adverse events (AEs)
measured 24 months
Incidence of laboratory abnormalities
measured 24 months
Incidence of electrocardiogram abnormalities
measured 24 months
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