ELVN-002-003 is an open-label, multicenter, multi-part, phase 1a/1b study of ELVN-002 with trastuzumab designed to evaluate its preliminary safety, tolerability, PK and preliminary efficacy in participants with advanced stage HER2 positive solid tumors.

ELVN-002 – oral HER2 TKI
Trastuzumab – IV HER2 immunotherapie

• Pathologically or histologically documented solid tumor
• Locally advanced or relapsed/refractory disease or unresectable metastatic disease
• HER2 positive
• ECOG 0-1
• No limitations on prior therapy
• LVEF > 50% by ECHO within 28 days of first dose
• Adequate bone marrow function.
• Adequate hepatic function

• Severe cardiac arrhythmias requiring treatment, symptomatic congestive heart failure, myocardial infarction within 28 days of first dose.
• History of another active malignancy within 2 years prior to the first dose.
• Serious medical or psychiatric illness
• Major surgery within 3 weeks of the first dose
• Active chronic liver disease
• Active infection requiring systemic therapy within 14 days of the first dose
• History of interstitial lung disease or pulmonary fibrosis.
• Treatment with anticancer therapy within a specific time window.
• Brain lesions requiring immediate local therapy
• Ongoing use of corticosteroids for CNS symptoms > 2 mg daily of dexamethasone or equivalent
• Leptomeningeal disease
• Uncontrolled seizures
• Ongoing adverse effects from prior treatment
• Corrected Qt interval of > 470 ms (females) or > 450 ms (males)
• Known hypersensitivity to a component of ELVN-002 or trastuzumab
• Primary immunodeficiency or known HIV infection