Studieoverzicht

Study name: ELVN-002-003 – A phase 1a/1b study of ELVN-002 combined with trastuzumab in advanced stage HER2+ solid tumors

Histology	NSCLC, all subtypes
Tumor stage	Stage III - IV
Host / recruiting site 1	Radboud UMC	Enrollment	Closed
Therapy line	Later line (≥2L)
Design	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.
Intervention	ELVN-002 – oral HER2 TKI Trastuzumab – IV HER2 immunotherapie
Key inclusion criteria	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
Key exclusion criteria	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
Contact information	Log in voor de contactinformatie