NCT05650879

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

A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients With HER2 Mutant Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Enliven Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There are 4 parts to the trial. Part 1 is a dose escalation with ELVN-002 monotherapy for people with advanced stage solid tumors that have a HER2 mutation, amplification or high HER2 over-expression. Part 2 is an ELVN-002 monotherapy dose exploration where additional people may be enrolled at dose levels that have cleared the dose escalation in Part 1 to further evaluate the safety, tolerability, pharmacokinetics and clinical activity. Part 3 is a dose expansion of ELVN-002 monotherapy which will enroll up to 40 patients people with advanced stage HER2 mutant non-small cell lung cancer. Patients in Part 3 will be randomized 1:1 to receive one of two dose levels. Part 4 is a combination dose escalation where, based on the results of Part 1 and 2, a combination of ELVN-002 and either fam-trastuzumab deruxtecan-nxki (in HER2 mutant non-small cell lung cancer) or trastuzumab emtansine (in HER2 positive breast cancer) will be evaluated for safety and tolerability.

Conditions

• HER2 Mutant Non-small Cell Lung Cancer
• HER2-positive Metastatic Breast Cancer
• HER2 Gene Mutation
• HER2 Amplification

Interventions

Type	Name	Description
DRUG	ELVN-002	capsule
DRUG	Fam-Trastuzumab Deruxtecan-Nxki	intravenous
DRUG	Trastuzumab emtansine	intravenous

Timeline

• Start date: 2023-03-20
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2022-12-14
• Last updated: 2025-07-15

Locations

39 sites across 7 countries: United States, Australia, France, Italy, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study