What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those targeting HER2, include drugs like trastuzumab and lapatinib. Known side effects of these HER2 inhibitors can include diarrhea, rash, and, in some cases, more severe adverse events such as cardiotoxicity. Other common treatments for breast cancer, such as tamoxifen and aromatase inhibitors, can cause hot flashes, bone density loss, and cardiovascular risks. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several FDA-approved treatments for breast cancer target the HER2 receptor, similar to the investigational drug ELVN-002. Notable examples include trastuzumab (Herceptin), a monoclonal antibody that binds to the HER2 receptor, and pertuzumab (Perjeta), which also targets HER2 but at a different site, providing a complementary mechanism of action. Additionally, trastuzumab emtansine (Kadcyla) is an antibody-drug conjugate combining trastuzumab with a cytotoxic agent, delivering targeted chemotherapy to HER2-positive cancer cells. These treatments have significantly improved outcomes for patients with HER2-positive breast cancer.

What other types of research exist?

Promising novel alternatives to ELVN-002 for HER2-positive breast cancer patients include: 1) Dual antibody-based HER2 blockade as demonstrated in the APHINITY trial, which showed efficacy in the adjuvant setting. 2) Ado-trastuzumab emtansine (T-DM1), which has shown positive results in various trials. 3) Trastuzumab deruxtecan, which has shown efficacy in metastatic settings. 4) Combination therapies such as trastuzumab, pertuzumab, and docetaxel, which have been effective in advanced cases. These options should be discussed with a healthcare provider to determine the best individualized treatment plan.

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HER2 Inhibitor

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

Q: What is the mechanism of action of this treatment?

HER2 inhibitors, such as trastuzumab, are a common treatment for HER2-positive breast cancer. These drugs work by targeting the HER2 protein, which is overexpressed in some breast cancer cells, leading to uncontrolled growth. By binding to the HER2 receptors on the surface of cancer cells, these inhibitors block the signals that promote cell division and growth, thereby slowing or stopping tumor progression. This targeted approach is crucial for patients because it offers a more personalized treatment, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

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

Must not have

Active or chronic liver disease

Leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ELVN-002, a new drug, in people with cancers that have an abnormal HER2 gene. It aims to see if the drug is safe and can shrink these tumors, especially in advanced stage solid tumors and 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have ongoing liver problems.

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My cancer has spread to the lining of my brain and spinal cord.

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I need immediate treatment for a brain lesion.

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I have seizures that are not controlled by medication.

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I do not have severe heart problems like recent heart attacks or unstable chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Brain metastases response in Phase 1b monotherapy

Duration of response in Phase 1b monotherapy

Objective Response rate in Phase 1a monotherapy

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 80 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

~2290

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

HER2 inhibitors, such as trastuzumab, are a common treatment for HER2-positive breast cancer. These drugs work by targeting the HER2 protein, which is overexpressed in some breast cancer cells, leading to uncontrolled growth. By binding to the HER2 receptors on the surface of cancer cells, these inhibitors block the signals that promote cell division and growth, thereby slowing or stopping tumor progression. This targeted approach is crucial for patients because it offers a more personalized treatment, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Pharmacokinetic and pharmacodynamic evaluation of panitumumab in the treatment of colorectal cancer.Do our current clinical trial designs help to guide clinical practice?Promising novel therapies for the treatment of endometrial cancer.