drugset / Trial / NCT05650879

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

NCT05650879

Phase 1 Active not recruiting 198 enrolled Enliven Therapeutics
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2023-03-20
Primary completion
2026-07
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject ELVN-002 Unknown Oral
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg Intravenous
Subject Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous