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Clinical Trials List

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

2023-03-01 - 2026-10-30

Phase I

Recruiting5

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

    2026/02/01

Investigators and Locations

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 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
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee
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

Phase 1a Primary Objectives: • 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). • Evaluate the safety and tolerability of ELVN-002 alone and in combination with T-DXd or T-DM1. Phase 1a Secondary Objectives: • Evaluate the pharmacokinetic (PK) profile of ELVN-002 alone and in combination with T-DXd or T-DM1. • Evaluate the efficacy of ELVN-002 alone in human epidermal growth factor receptor 2 (HER2) mutations, HER2 amplification, or HER2 positivity (immunohistochemical staining [IHC]). Preliminary antitumor activity in solid tumors (3+ or IHC2+/in situ hybridization [ISH+]) • Evaluate the preliminary antitumor activity of ELVN-002 in combination with T-DXd in HER2-mutant non-small cell lung cancer (NSCLC) or in combination with T-DM1 in HER2-positive breast cancer Phase 1a exploratory objectives • Evaluate other measures of clinical benefit • Evaluate the benefit of ELVN-002 for brain metastases in HER2-mutant, HER2-amplified, or HER2-positive solid tumors • Evaluate potential biomarkers for ELVN-002 response/resistance • Evaluate the PK profile of the active metabolite of ELVN-002 • Evaluate DM1 and MAAA-1181a PK Profile of (Active Metabolites of T-DM1 and T-DXd when used in combination with ELVN-002) Phase 1b Primary Objective • To evaluate the safety and tolerability of ELVN-002 in the treatment of HER2-mutant NSCLC Phase 1b Secondary Objectives • To evaluate the clinical benefit of ELVN-002 in the treatment of HER2-mutant NSCLC • To evaluate the PK of ELVN-002 in HER2-mutant NSCLC Phase 1b Exploratory Objectives • To evaluate potential biomarkers of response/resistance to ELVN-002 in HER2-mutant NSCLC • To evaluate other measures of clinical benefit • To evaluate the benefit of ELVN-002 for brain metastases in HER2-mutant NSCLC • To evaluate the PK of the active metabolite of ELVN-002

Test Drug

膠囊劑
注射劑
注射劑

Active Ingredient

ELVN-002
trastuzumab deruxtecan
Trastuzumab Emtansine

Dosage Form

130
270
270

Dosage

45mg/capsule
100mg/vial

Endpoints

Phase 1a Primary Assessment Indicators

• Incidence of dose-limiting toxicities (DLTs)

• Incidence of adverse events (AEs), laboratory abnormalities, and electrocardiogram (ECG) abnormalities

Phase 1b Primary Assessment Indicators

• Incidence of AEs, clinical laboratory 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

    198 participants

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