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Protocol NumberELVN-002-001
NCT Number(ClinicalTrials.gov Identfier)NCT05650879

2023-03-01 - 2026-10-30

Phase I

Recruiting3

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase 1a/1b Study of ELVN-002 for the Treatment of Patients With HER2 Mutant Non-Small Cell Lung Cancer

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2024/05/29

Investigators and Locations

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

HER2 Mutant Non-small Cell Lung Cancer

Objectives

Main purpose of Phase 1a ‧ Determine the recommended dose (RD) for ELVN-002 alone and in combination with the antibody drug complex (ADC) fam-trastuzumab deruxtecan-nxki (T-DXd) or ado-trastuzumab emtansine (T-DM1) ‧ To evaluate the therapeutic safety and tolerability of ELVN-002 alone and in combination with T-DXd or T-DM1 Secondary Purpose of Issue 1a ‧ Evaluate the pharmacokinetic (PK) profile of ELVN-002 alone and in combination with T-DXd or T-DM1 ‧ To evaluate the preliminary efficacy of ELVN-002 alone in human epidermal growth factor receptor 2 (HER2) mutated, HER2 amplified, or HER2-positive (immunohistochemical stain [IHC] 3+ or IHC2+/in situ hybridization [ISH+]) solid tumors. tumor activity ‧ To evaluate the preliminary anti-tumor activity of ELVN-002 in combination with T-DXd in HER2-mutant non-small cell lung cancer (NSCLC) or with T-DM1 in HER2-positive breast cancer Issue 1a Exploratory Purpose ‧ Other measures to assess clinical benefit ‧ Evaluating the efficacy of ELVN-002 against brain metastases in HER2-mutated, HER2-amplified, or HER2-positive solid tumors ‧ Potential biomarkers for assessing ELVN-002 response/resistance ‧ Evaluate the PK profile of ELVN-002 active metabolites ‧ Evaluate the PK profile of DM1 and MAAA-1181a (active metabolites of T-DM1 and T-DXd when combined with ELVN-002) Main purpose of Phase 1b ‧ To evaluate the safety and tolerability of ELVN-002 for the treatment of HER2-mutated NSCLC Secondary Purpose of Issue 1b ‧ Evaluating the clinical efficacy of ELVN-002 in the treatment of HER2-mutated NSCLC ‧ Evaluate the PK of ELVN-002 for HER2 mutated NSCLC Issue 1b Exploratory Purpose ‧ Potential biomarkers to assess response/resistance to ELVN-002 in HER2-mutated NSCLC ‧ Other measures to assess clinical benefit ‧ Evaluating the efficacy of ELVN-002 on brain metastasis in HER2-mutated NSCLC ‧ Evaluate the PK of ELVN-002 active metabolites

Test Drug

ELVN-002ENHERTUKADCYLA

Active Ingredient

ELVN-002
trastuzumab deruxtecan
trastuzumab emtansine

Dosage Form

capsule
Injection
Injection

Dosage

45 mg/capsule, 180 mg/capsule
100 mg/vial
100 mg/vial or 160 mg/vial

Endpoints

Main evaluation indicators for Phase 1a
‧ Incidence of dose-limiting toxicities (DLT)
‧ Incidence of adverse events (AEs), laboratory test abnormalities, and electrocardiogram (ECG) abnormalities
Main evaluation indicators for Phase 1b
‧ Incidence of AEs, clinical laboratory test abnormalities, and ECG abnormalities

Inclution Criteria

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

Exclusion Criteria

Exclusion Criteria All Phases:

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)

The Estimated Number of Participants

  • Taiwan

    34 participants

  • Global

    178 participants

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