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Testing ELVN-002 for HER2 Mutant Non-Small Cell Lung Cancer

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

Phase 1 Interventional Enliven Therapeutics · NCT05650879

This study is testing a new drug called ELVN-002 to see if it can safely help people with HER2 mutant non-small cell lung cancer and HER2-positive metastatic breast cancer.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment198 (estimated)
Ages18 Years and up
SexAll
SponsorEnliven Therapeutics Industry-sponsored
Drugs / interventionstrastuzumab, chemotherapy, immunotherapy
Locations39 sites (Aurora, Colorado and 38 other locations)
Trial IDNCT05650879 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of ELVN-002 in patients with cancers exhibiting abnormal HER2 genes, specifically focusing on HER2 mutant non-small cell lung cancer and HER2-positive metastatic breast cancer. The trial consists of four parts: a dose escalation of ELVN-002 monotherapy, a dose exploration for further safety and efficacy evaluation, a dose expansion for advanced HER2 mutant non-small cell lung cancer, and a combination therapy assessment with other HER2-targeted treatments. The study will monitor drug concentration in the blood and its correlation with safety and clinical activity.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced stage solid tumors that have a HER2 mutation or amplification and have progressed after standard treatments.

Not a fit: Patients with known mutations in EGFR, ROS1, ALK, or BRAF V600E may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a new treatment option for patients with HER2 mutant cancers, potentially improving their outcomes.

How similar studies have performed: Other studies have shown promise with HER2-targeted therapies, suggesting potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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

Exclusion 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)

Where this trial is running

Aurora, Colorado and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HER2 Mutant Non-small Cell Lung CancerHER2-positive Metastatic Breast CancerHER2 Gene MutationHER2 AmplificationHER2 genetic alterationsHER2 mutationELVN-002Non-small cell lung cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.