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HER2 Inhibitor

ELVN-002 for Non-Small Cell Lung Cancer (HER2 Trial)

Phase 1
Recruiting
Research Sponsored by Enliven Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All Phases: Eastern Cooperative Oncology Group performance status of 0-1, left ventricular ejection fraction ≥ 50%, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 8.5 g/dL, absolute neutrophil count ≥1.0 x 10^9/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
Phase 1a Combination with T-DXd: Pathologically documented advanced stage NSCLC progressed after receiving at least 1 prior systemic therapy with HER2 mutation based on local/historical testing of tissue or circulating tumor DNA, and no known EGFR, ROS1, ALK, or BRAF V600E mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

HER2 Trial Summary

This trial tests a new drug (ELVN-002) to see if it's safe & effective at shrinking cancer with an abnormal HER2 gene, like non-small cell lung cancer.

Who is the study for?
This trial is for adults with advanced solid tumors, particularly non-small cell lung cancer (NSCLC), that have HER2 mutations and have progressed after standard treatments or are unsuitable for them. Participants must be in good physical condition with proper heart function and adequate blood counts. Those with brain lesions needing immediate treatment, active infections, uncontrolled seizures, certain heart conditions, or another active cancer within the last 2 years cannot join.Check my eligibility
What is being tested?
The trial is testing ELVN-002's safety at various doses in patients with HER2 gene abnormalities. It will also measure how much of the drug stays in the blood over time and whether it effectively shrinks tumors. Some participants will receive ELVN-002 alone while others may get it alongside other drugs like Fam-Trastuzumab Deruxtecan-Nxki depending on their specific type of cancer.See study design
What are the potential side effects?
Potential side effects include reactions to infusion such as fever or chills; organ inflammation; fatigue; nausea; low blood cell counts leading to increased infection risk or bleeding problems; liver issues; and possible heart complications like irregular heartbeat.

HER2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You should have good overall health, normal heart function, and specific levels of blood cells, liver function, and kidney function.
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My advanced NSCLC has worsened after treatment and has a HER2 mutation but no EGFR, ROS1, ALK, or BRAF V600E mutations.
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My advanced cancer has not responded to standard treatments and is HER2 positive.
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I have advanced non-squamous NSCLC with a HER2 mutation and no EGFR, ROS1, ALK, or BRAF V600E mutations.
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My breast cancer is HER2 positive and I've had specific treatments.

HER2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events in Phase 1a combination with T-DM1
Incidence of adverse events in Phase 1a combination with T-DXd
Incidence of adverse events in Phase 1a monotherapy
+12 more
Secondary outcome measures
Brain metastases response in Phase 1b monotherapy
Duration of response in Phase 1b monotherapy
Objective Response rate in Phase 1a monotherapy
+7 more

HER2 Trial Design

5Treatment groups
Experimental Treatment
Group I: Phase 1b Monotherapy Dose ExpansionExperimental Treatment1 Intervention
ELVN-002 will be administered either once or twice daily. A maximum of 40 patients will enroll in this arm. Patients will be randomized 1:1 to one of two dose levels. ELVN-002 is an oral capsule. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason.
Group II: Phase 1a Monotherapy Dose ExplorationExperimental Treatment1 Intervention
ELVN-002 will be administered either once or twice daily. A maximum of 60 patients will enroll in this arm. A maximum of 10 patients may be enrolled at a single dose or tumor type. ELVN-002 is an oral capsule. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason.
Group III: Phase 1a Monotherapy Dose EscalationExperimental Treatment1 Intervention
ELVN-002 will be administered either once or twice daily. Each cohort of patients will receive a higher dose. ELVN-002 is an oral capsule. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason.
Group IV: Phase 1a Combination Dose Escalation with T-DXdExperimental Treatment2 Interventions
ELVN-002 will be administered either once or twice daily starting on Day 1. ELVN-002 is an oral capsule. Each cohort will receive a higher dose of ELVN-002. All patients in all cohorts will initiate with 5.4mg/kg of intravenous T-DXd once every 3 weeks starting on day 22 of the study. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason.
Group V: Phase 1a Combination Dose Escalation with T-DM1Experimental Treatment2 Interventions
ELVN-002 will be administered either once or twice daily starting on Day 1. ELVN-002 is an oral capsule. Each cohort will receive a higher dose of ELVN-002. All patients in all cohorts will initiate with 3.6 mg/kg of intravenous T-DM1 once every 3 weeks starting on day 22 of the study. Duration of treatment will be until disease progression or patient discontinues ELVN-002 for another reason.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab emtansine
2010
Completed Phase 4
~2220

Find a Location

Who is running the clinical trial?

Enliven TherapeuticsLead Sponsor
2 Previous Clinical Trials
435 Total Patients Enrolled

Media Library

ELVN-002 (HER2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05650879 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Phase 1a Combination Dose Escalation with T-DXd, Phase 1a Monotherapy Dose Exploration, Phase 1a Combination Dose Escalation with T-DM1, Phase 1a Monotherapy Dose Escalation, Phase 1b Monotherapy Dose Expansion
Non-Small Cell Lung Cancer Clinical Trial 2023: ELVN-002 Highlights & Side Effects. Trial Name: NCT05650879 — Phase 1
ELVN-002 (HER2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05650879 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an inherent risk associated with Phase 1a Monotherapy Dose Escalation?

"Our team at Power has assessed that the safety of Phase 1a Monotherapy Dose Escalation is a 1, due to this being an initial trial with limited evidence of efficacy and safety."

Answered by AI

Is this research endeavor accepting new participants?

"Confirmed, participants are currently being sought for the trial. As per records on clinicaltrials.gov, this research was posted online in March of 2023 and underwent a recent update at the start of February that same year."

Answered by AI

To what extent is this experiment being populated?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was initially made available on March 1st 2023, is actively recruiting participants. This particular medical study seeks 178 individuals from a single site."

Answered by AI

What is the specific aim of this research endeavor?

"The primary assessment metric of this two-year medical trial will be to measure the frequency of dose limiting toxicities in Phase 1a monotherapy. Secondary metrics include confirming response rate per RECIST 1.1, determining duration from first response to progression or death, and ascertaining brain metastases responses for patients with measurable brains metastases at baseline."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
2023. "ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05650879.
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~119 spots leftby Jul 2026
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