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(Slides)

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ELVN-002 is a potent and selective inhibitor of HER2, designed to provide a therapeutic option for patients with HER2-altered solid tumors. It has demonstrated 100-fold selectivity over EGFR and has shown antitumor activity in in vitro and in vivo models, including tumor regressions in an intracranial model. It has also shown additive antitumor activity in combination with trastuzumab deruxtecan.<br /><br />The ELVN-002-001 study is a phase 1a/b trial evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of ELVN-002 monotherapy and in combination with T-DXd or T-DM1 in patients with solid tumors with HER2 alterations, including HER2-mutant NSCLC and HER2-overexpressed MBC. The study will include dose escalation and expansion cohorts, with the primary objective of determining the recommended dose of ELVN-002 alone and in combination with T-DXd or T-DM1, as well as evaluating the safety and tolerability of the treatments.<br /><br />The study design includes multiple dose escalation cohorts for monotherapy and combination therapy, and a dose expansion phase for monotherapy in HER2-mutant NSCLC. The endpoints of the study include dose-limiting toxicities, incidence of adverse events, PK parameters, and preliminary antitumor activity.<br /><br />The study is currently enrolling patients at various locations. ELVN Therapeutics is sponsoring the study, and the authors would like to acknowledge the investigators, site support staff, and patients for their participation. Editorial support for the study was provided by Bio Connections LLC.<br /><br />In summary, ELVN-002 is a promising HER2 inhibitor being evaluated in a phase 1a/b study for the treatment of solid tumors with HER2 alterations. The study aims to determine the safety, efficacy, and recommended doses of ELVN-002 as monotherapy and in combination with T-DXd or T-DM1.

Asset Subtitle

Samantha Bowyer

Meta Tag

Speaker Samantha Bowyer

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

ELVN-002

HER2 inhibitor

solid tumors

HER2-altered

selective inhibitor

antitumor activity

phase 1a/b trial

safety

efficacy

recommended dose