2023 World Conference on Lung Cancer (Posters)-P2.09. Trials in Progress: Phase 1a/b study of ELVN-002, in Solid Tumors with HER2 Mutations, Amplification or Overexpression

P2.09. Trials in Progress: Phase 1a/b study of ELVN-002, in Solid Tumors with HER2 Mutations, Amplification or Overexpression - PDF(Abstract)

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This document describes a clinical trial in progress titled "Trials in Progress: Phase 1a/b study of ELVN-002, in Solid Tumors with HER2 Mutations, Amplification or Overexpression". The study is investigating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ELVN-002, a tyrosine kinase inhibitor (TKI) of HER2, in solid tumors with HER2 pathway activation, including HER2-mutant non-small cell lung cancer (NSCLC). <br /><br />The study is a phase 1 open-label, multi-center trial that includes dose escalation and expansion. Eligible patients must have progressed or are not suitable for standard treatment, have a documented HER2 mutation, amplification, or overexpression, and have an ECOG performance status of 0-1. Patients with asymptomatic brain metastases are also eligible. The study will involve continuous dosing of ELVN-002 in 21-day cycles until disease progression or unacceptable toxicity. Dose escalation decisions will follow a Bayesian Design, and dose escalation may continue until the maximum tolerated dose is identified. <br /><br />In the phase 1b expansion, two recommended doses for monotherapy will be chosen based on dose escalation data, and patients with HER2-mutant NSCLC and measurable disease will be randomized between the two dose levels. These patients must have received at least one prior therapy, including a platinum-based chemotherapy with or without immunotherapy. <br /><br />The study aims to evaluate the safety and efficacy of ELVN-002 in solid tumors with HER2 pathway activation and explore the combination of ELVN-002 with other drugs, such as T-DM1 in HER2-positive breast cancer. The trial has already opened for enrollment in February 2023 and is sponsored by Enliven Therapeutics.<br /><br />In summary, this ongoing phase 1 clinical trial seeks to assess the safety and potential anti-tumor activity of ELVN-002, a selective TKI of HER2, in patients with solid tumors with HER2 mutations, amplification, or overexpression, including HER2-mutant NSCLC. The trial also aims to evaluate the combination of ELVN-002 with other targeted therapies in HER2-positive breast cancer.

Asset Subtitle

Samantha Bowyer

Meta Tag

Speaker Samantha Bowyer

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

clinical trial

ELVN-002

HER2 mutations

solid tumors

tyrosine kinase inhibitor

safety

dose escalation

HER2-mutant NSCLC

combination therapy

Enliven Therapeutics