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Active, not recruiting Phase 1 Interventional

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer

ClinicalTrials.gov ID: NCT05650879

Public ClinicalTrials.gov record NCT05650879. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 4:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients With HER2 Mutant Non-Small Cell Lung Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time. The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer.

Study identification

NCT ID
NCT05650879
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1
Lead sponsor
Enliven Therapeutics
Industry
Enrollment
198 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 20, 2023 (Actual)
Primary completion
Jul 2026 (Estimated)
Completion
Jul 2026 (Estimated)
Last update posted
Jul 15, 2025

2023 – 2026

United States locations

U.S. sites
5
U.S. states
4
U.S. cities
5
Facility City State ZIP Site status
University of Colorado - Anschutz Medical Campus - PPDS Aurora Colorado 80045 —
Advent Health Orlando Orlando Florida 32804 —
BRCR Medical Center Inc Plantation Florida 33322 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
NEXT/Virginia Cancer Specialists Fairfax Virginia 22031 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05650879, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 15, 2025 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05650879 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →