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New drug cocktail targets Hard-to-Treat HER2 cancers

NCT ID NCT06328738

Disease control Sponsor: Enliven Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new drug called ELVN-002 in combination with trastuzumab and chemotherapy for people with advanced HER2-positive solid tumors, including breast, gastric, and colorectal cancers. The main goal is to find a safe dose and understand side effects. About 275 participants will be enrolled across multiple cancer types.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ELVN-002 (a targeted drug) combined with trastuzumab and chemotherapy drugs
What this could lead to
If successful, this could point toward a new treatment option for people with advanced HER2-positive cancers that have stopped responding to standard therapies.
What could go wrong
This is a very early (Phase 1) trial focused on safety and dosing, not yet on effectiveness. It is small and may not lead to a proven treatment. Side effects from the drug combinations are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 275 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pathologically or histologically documented solid tumor. * Locally advanced or relapsed/refractory disease or unresectable metastatic disease. * HER2-positive disease based on the following local testing: * Colorectal cancer: IHC3+, IHC2+/ISH+, NGS amplification by tissue (no RAS or BRAF mutation allowed) * Breast cancer: IHC3+ or IHC2+/ISH+ by tissue * Gastric cancer: IHC3+ or IHC2+/ISH+ by tissue * Other cancers: IHC3+, IHC2+/ISH+, NGS amplification by tissue or ctDNA * Prior therapies for Part 1 (Dose Escalation ELVN-002 + trastuzumab): * Colorectal cancer: treated with prior fluoropyrimidine, oxaliplatin, irinotecan-based regimens, anti-epidermal growth factor receptor (EGFR) treatment (if clinically indicated), anti-vascular endothelial growth factor (VEGF) treatment (if clinically indicated), and an anti-programmed death ligand 1 (PD-(L)-1) treatment (if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR) * Breast cancer: treated with prior taxane, pertuzumab, trastuzumab, and fam-trastuzumab deruxtecan (T-DXd) if available and appropriate based on local standard of care and investigator's assessment * Gastric cancer: treated with trastuzumab/platinum fluorouracil containing regimen and T-DXd. * Other cancers: progressed during or after ≥ 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease * Prior HER2 targeted therapy is allowed * Prior therapies for Part 2 (Phase 1a Dose Escalation ELVN-002 + trastuzumab + chemotherapy): * Colorectal cancer: candidate for CAPEOX (capecitabine and oxaliplatin) or mFOLFOX6 (5-FU, LCV and oxaliplatin), and treated, if clinically indicated, with an anti-programmed death ligand 1 (PD-(L)-1) treatment (if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR). Prior HER2 targeted therapy is allowed. * Breast cancer: candidate for capecitabine, paclitaxel or eribulin, and treated with prior taxane, pertuzumab, trastuzumab, and T-DXd, if available and appropriate, based on local standard of care and investigator's assessment. No prior HER2 targeted tyrosine kinase inhibitor therapy (antibody-drug conjugates and antibodies are allowed), no prior capecitabine (for the capecitabine cohort), no prior eribulin (for the eribulin cohort), and no taxane as immediate prior therapy (paclitaxel cohort). * Prior therapies for Part 3 (Phase 1b Dose Expansion ELVN-002 + trastuzumab): * Colorectal cancer: treated with prior fluoropyrimidine, oxaliplatin, irinotecan-based regimens, anti-epidermal growth factor receptor (EGFR) treatment (if clinically indicated), anti-vascular endothelial growth factor (VEGF) treatment (if clinically indicated), and an anti-programmed death ligand 1 (PD-(L)-1) treatment if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR). No prior HER2 targeted therapy. * Breast cancer: treated with prior taxane, pertuzumab, trastuzumab, and T-DXd if available and appropriate based on local standard of care and investigator's assessment. No prior HER2 targeted tyrosine kinase inhibitor therapy (antibody-drug conjugates and antibodies are allowed). * Gastric cancer: treated with prior trastuzumab/platinum fluorouracil containing regimen and T-DXd. No prior HER2 targeted therapy. * Other cancers: Progressed during or after ≥ 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease. No prior HER2 targeted therapy. * Prior therapies for Part 4 (Phase 1b Dose Expansion ELVN-002 + trastuzumab + chemotherapy): \* Colorectal cancer: candidate for CAPEOX or mFOLFOX6 and not a candidate for first-line anti-programmed death ligand 1 (PD-(L)-1) treatment (if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR). No prior therapy for metastatic disease (1 cycle of mFOLFOX6 or 1 cycle of CAPEOX allowed). No prior HER2 targeted therapy. * At least 1 measurable lesion based on RECIST v 1.1 within 6 weeks before the first dose of ELVN-002 (Part 3 and Part 4 only; Phase 1b Dose Expansion cohorts) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Adequate hematological, hepatic, renal, and cardiac function Exclusion Criteria: * Treatment with anticancer therapy within a specific time before the first dose: * Chemotherapy (including ADC) ≤ 3 weeks * Immunotherapy ≤ 4 weeks * Hormonal therapy ≤ 2 weeks * TKI ≤ 2 weeks * Any experimental therapy ≤ 3 weeks or 5 half-lives, whichever is longer * Radiotherapy-wide therapy ≤ 3 weeks * Radiotherapy limited field (including stereotactic brain) ≤ 2 weeks * Antibody ≤ 3 weeks * Any brain lesion requiring immediate local therapy * Ongoing use of corticosteroids for central nervous system (CNS) symptoms at a dose of \> 2 mg daily of dexamethasone (or equivalent) * Leptomeningeal disease * Uncontrolled seizures * Participants for any chemotherapy cohort: ongoing Grade 2 or higher neuropathy of any cause * Inability to swallow pills or any significant gastrointestinal disease that would preclude adequate oral absorption of medications. * Ongoing adverse effects from prior treatment \> CTCAE Grade 1 except for Grade 2 alopecia * Corrected QT interval (QTc) of \>470 milliseconds (ms) for females or \>450 ms for males

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm gastric cancer HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer HER2 amplification HER2-positive breast cancer HER2-positive gastric cancer HER2-positive solid tumors

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Italy

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, Italy

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia, Italy

  • BRCR Medical Center Inc.

    Plantation, Florida, 33322, United States

  • CHA Bundang Medical Center

    Seongnam-si, 13496, South Korea

  • CHU de Liège

    Liège, Belgium

  • CHU de Poitiers

    Poitiers, 8600, France

  • Clinica univeritaria Navarra - Pamplonas

    Pamplona, Spain

  • Clinica universitaria Navarra - Madrid

    Madrid, 28027, Spain

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Italy

  • Fondazione Policlinico A. Gemelli IRCCS

    Rome, 00168, Italy

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, Spain

  • GZA Ziekenhuizen - Campus Sint-Augustinus

    Wilrijk, Belgium

  • Hospital Beata Maria Ana

    Madrid, 28007, Spain

  • Hospital Universitari Dexeus - Grupo Quironsalud

    Barcelona, Spain

  • Institut de Cancérologie Strasbourg Europe

    Strasbourg, 67033, France

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, France

  • Institut du Cancer de Montpellier - Val D'Aurelle

    Montpellier, 34090, France

  • Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

    Barcelona, Spain

  • Istituto Europeo di Oncologia

    Milan, Italy

  • NEXT Oncology-Hospital Quironsalud Barcelona

    Barcelona, 08023, Spain

  • NEXT Virginia

    Fairfax, Virginia, 22031, United States

  • Radboud UMC

    Nijmegen, Netherlands

  • START Barcelona_HM Nou Delfos

    Barcelona, 08023, Spain

  • START Madrid - Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Seoul National University Hospital

    Soeul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, 16247, South Korea

  • Washington University

    St Louis, Missouri, 63110, United States

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