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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: Active Phase 1 study of HER2-positive Metastatic Breast Cancer and HER2 Gene Mutation, sponsored by Enliven Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the registry record for NCT05650879 still lists
NCT05650879 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 106-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (87% higher).
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Where NCT05650879's enrollment target sits among peer trials
198 3rd of 11 higher than 9 of 11 other HER2-positive Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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