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NCT05650879 · ClinicalTrials.gov registry record · Phase 1
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
A Phase 1 study of HER2-positive Metastatic Breast Cancer and HER2 Gene Mutation, sponsored by Enliven Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 198
- Enrollment target
- 20
- Study locations
NCT05650879 is a Phase 1 study of HER2-positive Metastatic Breast Cancer and HER2 Gene Mutation that is active but no longer recruiting, run by Enliven Therapeutics. The registered enrollment target is 198 participants, above the 106-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (87% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT05650879, a Phase 1 study of HER2-positive Metastatic Breast Cancer and HER2 Gene Mutation, is active but no longer recruiting, sponsored by Enliven Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 198 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Trastuzumab emtansine
- DRUG Fam-Trastuzumab Deruxtecan-Nxki
- DRUG ELVN-002
Study Locations (20)
Other
- Blacktown Hospital - Darlinghurst
- Centre Georges François Leclerc - Dijon
- Centre Léon Berard - Lyon
- Institut Gustave Roussy (IGR) - Villejuif
- Fondazione Policlinico Universitario A. Gemelli - Roma
Florida
- Advent Health Orlando - Orlando
- BRCR Medical Center Inc - Plantation
Colorado
- University of Colorado - Anschutz Medical Campus - PPDS - Aurora
Massachusetts
- Dana Farber Cancer Institute - Boston
Virginia
- NEXT/Virginia Cancer Specialists - Fairfax
New South Wales
- Macquarie University Hospital - Westmead
Western Australia
- Linear Clinical Research Limited - Nedlands
Bouches-du-Rhône
- Hôpital de la Timone Centre d'essais en cancérologie de Marseille (CEPCM-CLIPP) - Marseille
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2023-03-20 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05650879
The ClinicalTrials.gov registry entry for NCT05650879 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 106-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (87% higher). The listed sponsor is Enliven Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with HER2-positive Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab emtansine is the first listed.
NCT05650879 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT05650879 about?
NCT05650879 is a clinical study titled "ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer". 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 differen...
What is the current status of trial NCT05650879?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 198 participants. The study started on 2023-03-20. Estimated completion is 2026-07.
What conditions does trial NCT05650879 study?
This clinical trial studies the following conditions: HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification, HER2 Mutant Non-small Cell Lung Cancer.
What interventions are being tested in trial NCT05650879?
The interventions under investigation include: Trastuzumab emtansine (DRUG), Fam-Trastuzumab Deruxtecan-Nxki (DRUG), ELVN-002 (DRUG).
Who is sponsoring clinical trial NCT05650879?
This trial is sponsored by Enliven Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05650879 being conducted?
This trial has 20 study locations across Colorado, Florida, Massachusetts, Virginia, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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