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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedELVN-002 and Fam-Trastuzumab Deruxtecan-Nxki

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · HER2 · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 15, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?39 U.S. locations

Locations may change over time.

Who runs it?Enliven Therapeutics

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Enliven Therapeutics
Interventions being studied: Drug: ELVN-002; Drug: Fam-Trastuzumab Deruxtecan-Nxki; Drug: Trastuzumab emtansine

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

HER2→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Phase 1a Monotherapy Dose Escalation and Exploration:
Pathologically documented advanced stage solid tumor
Progressed following all standard treatment or not appropriate for standard treatment
HER2 mutation, HER2 amplification or HER2 positive based on local testing Phase 1b Monotherapy
Pathologically documented unresectable and/or metastatic non-squamous NSCLC
HER2 mutation identified by tissue (fresh or archival) or ctDNA. Local testing for up to 20 patients the remainder centrally confirmed.
Measurable disease
No known epidermal growth factor receptor (EGFR), ROS1, anaplastic lymphoma kinase (ALK), or BRAF V600E mutation
Progressed after receiving at least 1 prior systemic therapy including a platinum-based chemotherapy with or without immunotherapy, or not appropriate for standard treatment.
No prior HER2 tyrosine kinase inhibitor. Prior HER2 directed antibodies or anti-body drug conjugates are allowed
No limit on prior number of therapies Phase 1a Combination with T-DXd
Pathologically documented advanced stage NSCLC
Progressed after receiving at least 1 prior systemic therapy.
HER2 mutation based on local/historical testing of tissue or circulating tumor DNA
No known EGFR, ROS1, ALK, or BRAF V600E mutation
No prior T-DXd
No clinically severe pulmonary compromise
No limit on prior number of therapies Phase 1a Combination Breast Cancer
Documented HER2 positive (Immunohistochemical \[IHC\] 3+ or IHC2+/in situ hybridization (ISH+) breast cancer
Must have previously received trastuzumab, a taxane, and T-DXd (if available and appropriate) in the metastatic setting.
No limit on prior number of therapies
No prior T-DM1 All Phases
Eastern Cooperative Oncology Group performance status of 0-1
Left ventricular ejection fraction ≥ 50%
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 8.5 g/dL
Absolute neutrophil count ≥1.0 x 109/L
Total bilirubin \< 1.5 times upper limit of normal range (ULN), except for patients with Gilbert's syndrome
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \< 3 times ULN. In the setting of liver metastases \< 5 times ULN.
Creatinine clearance ≥ 60 mL/minute

Reasons someone may not be able to joinExclusion criteria

All Phases:
Severe cardiac arrhythmias, requiring treatment, symptomatic congestive heart failure, myocardial infarction within 28 days prior to first dose, or unstable angina.
Another active malignancy within 2 years except basal cell skin cancer and carcinoma in situ treated curatively
Active or chronic liver disease
Active infection requiring systemic therapy within 14 days before the first dose
Brain lesion requiring immediate local therapy
Leptomeningeal disease
Uncontrolled seizures
Corrected QT interval (QTc) of \>470 milliseconds (ms) females or \>450 ms for males by Fridericia (QTcF)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Colorado - Anschutz Medical Campus - PPDSAurora, Colorado
Advent Health OrlandoOrlando, Florida
BRCR Medical Center IncPlantation, Florida
Dana Farber Cancer InstituteBoston, Massachusetts
NEXT/Virginia Cancer SpecialistsFairfax, Virginia
Macquarie University HospitalWestmead, New South Wales
Linear Clinical Research LimitedNedlands, Western Australia
Blacktown HospitalDarlinghurst
Hôpital de la Timone Centre d'essais en cancérologie de Marseille (CEPCM-CLIPP)Marseille, Bouches-du-Rhône
Hôpital PontchaillouRennes, Brittany Region
Centre Francois BaclesseCaen, Calvados
EDOG - Institut Bergonie - PPDSBordeaux, Gironde

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 15, 2025. Always confirm current availability with the study team.

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