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

Study acronym: HER2
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 15, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Re-verified, no change to tracked fieldsv24
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 39 of 39 sites
    v23
  3. Site details revised at 7 of 39 sitesv22
  4. Site details revised at 7 of 39 sitesv21
  5. Enrollment target: 178 to 198v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 38 to 39v19
  2. Study sites: 37 to 38v18
  3. Study sites: 32 to 37v17
  4. Study sites: 30 to 32v16
  5. Study sites: 27 to 30v15
  6. Study sites: 22 to 27v14
  7. Study sites: 21 to 22v13
  8. Study sites: 20 to 21v12
  9. Study sites: 15 to 20v11
  10. Study sites: 13 to 15v10
  11. Study sites: 8 to 13v9
  12. Study sites: 6 to 8v8
  13. Study sites: 5 to 6v7
  14. Study sites: 4 to 5v6
  15. Study sites: 3 to 4v5
  16. Study sites: 2 to 3
    • Start date changed from estimate of Mar 2023 to Mar 20, 2023
    v4
  17. Study sites: 1 to 2v3
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Enliven Therapeutics
4 trials monitored
See all monitored trials
Breast Cancer
5,418 trials monitored
See 296 trials at risk
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,078 trials monitored
See 172 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT05650879
Lead Sponsor Enliven Therapeutics
Conditions
(from sponsor)		 HER2 Mutant Non-small Cell Lung Cancer, HER2-positive Metastatic Breast Cancer, HER2 Gene Mutation, HER2 Amplification
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 198 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov