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

Study Identifier:
ELVN-002-001
CT.gov Identifier:
NCT05650879
EudraCT Identifier:
202250000000
EU Trial (CTIS) Number:
2022-502695-23-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

To assess the safety, tolerability, pharmacokinetics and clinical activity of ELVN-002 in patients with HER2 mutant non-small cell lung cancer.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Small Cell Lung
  • Breast Cancers
  • Gene Mutations
  • Biomarkers
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1a Monotherapy Dose Escalation
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  • Drug: Experimental: Phase 1a Monotherapy Dose Exploration
  • Drug: Experimental: Phase 1b Monotherapy Dose Expansion
  • Drug: ELVN-002 is an oral capsule. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason.
  • Drug: Drug: ELVN-002
  • Drug: Experimental: Phase 1a Combination Dose Escalation with T-DXd
  • Drug: Drug: Fam-Trastuzumab Deruxtecan-Nxki
  • Drug: Experimental: Phase 1a Combination Dose Escalation with T-DM1
  • Drug: Drug: Trastuzumab emtansine
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • Phase 1a Monotherapy Dose Escalation and Exploration:
    • Pathologically documented advanced stage solid tumor
    • Progressed following all standard treatment or not appropriate for standard treatment
    • HER2 mutation, HER2 amplification or HER2 positive based on local testing
    • Phase 1b Monotherapy
    • Pathologically documented unresectable and/or metastatic non-squamous NSCLC
    • HER2 mutation identified by tissue (fresh or archival) or ctDNA. Local testing for up to 20 patients the remainder centrally confirmed.
    • Measurable disease
    • No known epidermal growth factor receptor (EGFR), ROS1, anaplastic lymphoma kinase (ALK), or BRAF V600E mutation
    • Progressed after receiving at least 1 prior systemic therapy including a platinum-based chemotherapy with or without immunotherapy, or not appropriate for standard treatment.
    • No prior HER2 tyrosine kinase inhibitor. Prior HER2 directed antibodies or anti-body drug conjugates are allowed
    • No limit on prior number of therapies
    • Phase 1a Combination with T-DXd
    • Pathologically documented advanced stage NSCLC
    • Progressed after receiving at least 1 prior systemic therapy.
    • HER2 mutation based on local/historical testing of tissue or circulating tumor DNA
    • No known EGFR, ROS1, ALK, or BRAF V600E mutation
    • No prior T-DXd
    • No clinically severe pulmonary compromise
    • No limit on prior number of therapies
    • Phase 1a Combination Breast Cancer
    • Documented HER2 positive (Immunohistochemical [IHC] 3+ or IHC2+/in situ hybridization (ISH+) breast cancer
    • Must have previously received trastuzumab, a taxane, and T-DXd (if available and appropriate) in the metastatic setting.
    • No limit on prior number of therapies
    • No prior T-DM1
    • All Phases
    • Eastern Cooperative Oncology Group performance status of 0-1
    • Left ventricular ejection fraction ≥ 50%
    • Platelet count ≥ 100 x 109/L
    • Hemoglobin ≥ 8.5 g/dL
    • Absolute neutrophil count ≥1.0 x 109/L
    • Total bilirubin < 1.5 times upper limit of normal range (ULN), except for patients with Gilbert's syndrome
    • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 3 times ULN. In the setting of liver metastases < 5 times ULN.
    • Creatinine clearance ≥ 60 mL/minute
    • Other key eligibility criteria are ECOG performance status 0-1, adequate bone marrow, renal and liver function, and a left ventricular ejection fraction of >50%. Patients with treated or untreated asymptomatic brain metastases are eligible.
    Exclusion criteria
    • Severe cardiac arrhythmias, requiring treatment, symptomatic congestive heart failure, myocardial infarction within 28 days prior to first dose, or unstable angina.
    • Another active malignancy within 2 years except basal cell skin cancer and carcinoma in situ treated curatively
    • Active or chronic liver disease
    • Active infection requiring systemic therapy within 14 days before the first dose
    • Brain lesion requiring immediate local therapy
    • Leptomeningeal disease
    • Uncontrolled seizures
    • Corrected QT interval (QTc) of >470 milliseconds (ms) females or >450 ms for males by Fridericia (QTcF)

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Small Cell Lung
    Breast Cancers
    Gene Mutations
    Biomarkers