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

Running, not enrolling · Phase 1

Conditions studied: HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification

In brief

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.

Key facts

Study ID

NCT05650879

Run by

Enliven Therapeutics

People needed

198

Starts

2023-03-20

Expected to finish

2026-07-01

Last updated by the study team

2025-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Colorado - Anschutz Medical Campus - PPDS — Aurora, Colorado, United States
• Advent Health Orlando — Orlando, Florida, United States
• BRCR Medical Center Inc — Plantation, Florida, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• NEXT/Virginia Cancer Specialists — Fairfax, Virginia, United States
• Macquarie University Hospital — Westmead, New South Wales, Australia
• Linear Clinical Research Limited — Nedlands, Western Australia, Australia
• Blacktown Hospital — Darlinghurst, Australia
• Hôpital de la Timone Centre d'essais en cancérologie de Marseille (CEPCM-CLIPP) — Marseille, Bouches-du-Rhône, France
• Hôpital Pontchaillou — Rennes, Brittany Region, France
• Centre Francois Baclesse — Caen, Calvados, France
• EDOG - Institut Bergonie - PPDS — Bordeaux, Gironde, France
• Centre Georges François Leclerc — Dijon, France
• Centre Léon Berard — Lyon, France
• Institut Gustave Roussy (IGR) — Villejuif, France
• Fondazione IRCCS San Gerardo dei Tintori — Monza, Lombardy, Italy
• Fondazione del Piemonte per l'Oncologia (IRCCS) — Candiolo, Piedmont, Italy
• SOC Oncologia Medica e dei Tumori lmmunocorrelati, Centro Di Riferimento Oncologico Di Aviano (CRO) IRCCS — Aviano, Pordenone, Italy
• Azienda Ospedaliero Universitaria delle Marche — Ancona, The Marches, Italy
• Fondazione Policlinico Universitario A. Gemelli — Roma, Italy
• Unità Operativa Oncologia medica ed Ematologia — Rozzano, Italy
• The Catholic University of Korea, St. Vincent's Hospital — Suwon, Gyeonggido, South Korea
• Gachon University Gil Medical Center — Incheon, South Korea
• Severence Hospital, Yonsei University — Seoul, South Korea
• Samsung Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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