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New pill takes aim at hard-to-treat HER2 cancers

NCT ID NCT06253871

Disease control Sponsor: Iambic Therapeutics, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 2 times

Summary

This early-stage trial tests a new drug called IAM1363 in adults with advanced cancers that have HER2 alterations, including breast, lung, and stomach cancers that have spread to the brain. The study aims to find the safest dose and see if the drug can shrink tumors. About 383 participants will take the pill by mouth, and researchers will monitor side effects and how well the cancer responds.

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 383 people

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

Started

Mar 2024

Expected to finish

Dec 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.

Key Inclusion Criteria: * Age ≥ 18 years * Have relapsed/refractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required * Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy * Have radiographically measurable disease by RECIST v1.1 and/or RANO-BM * Eastern Cooperative Oncology Group (ECOG) performance score 0-1 * Have adequate baseline hematologic, liver and renal function * Have left ventricular ejection fraction (LVEF) ≥ 50% * Able to swallow oral medication Key Exclusion Criteria: * Clinically significant cardiac disease * Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \>350/mm3 and undetectable viral load) are eligible * Current active liver disease including hepatitis A, hepatitis B , or hepatitis C * Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption * Uncontrolled diabetes * History of solid organ transplantation * History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1 * Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible) * Participants requiring immediate local therapy for brain metastases

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

brain cancer breast neoplasm colorectal carcinoma gastric cancer gastric neoplasm gastroesophageal cancer HER2 positive breast carcinoma neoplasm non-small cell lung carcinoma urinary bladder carcinoma

As listed by the trial registrant

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

Brain metastases from HER2 and breast cancer Brain metastases from solid tumors CNS metastases HER2 HER2 + breast cancer HER2 + gastric cancer HER2 mutation-related tumors HER2-positive bladder cancer HER2-positive breast cancer HER2-positive colorectal cancer HER2-positive gastroesophageal cancer HER2-positive solid tumors NSCLC (non-small cell lung cancer)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    53 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3

    RECRUITING

    Florence, 50134, Italy

  • Centre Georges François Leclerc

    RECRUITING

    Dijon, 21079, France

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Comprehensive Hematology Oncology

    RECRUITING

    St. Petersburg, Florida, 33709, United States

  • Cork University Hospital, Wilton

    RECRUITING

    Cork, T12DC4A, Ireland

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • Henry Ford Cancer Institute

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Clinico Universitario de Valencia (INCLIVA)

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Regional Málaga

    RECRUITING

    Málaga, 29011, Spain

  • Hospital Universitario Vall dHebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole Institut Claudius Regaud "

    RECRUITING

    Toulouse, 31059, France

  • Institut de Cancerologie de l'Ouest

    RECRUITING

    Saint-Herblain, 44805, France

  • Istituto Europeo di Oncologia (IEO)

    RECRUITING

    Milan, 20141, Italy

  • MD Anderson Cancer Center - University of Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • Mary Crowley Cancer Research

    RECRUITING

    Dallas, Texas, 75230, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • NEXT Oncology - Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Oncology - Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Netherlands Cancer Institute-Antoni van Leeuwenhoek

    RECRUITING

    Amsterdam, 1066CX, Netherlands

  • OU Health Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Oxford University Hospitals NHS Foundation Trust Churchill Hospital

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Providence Cancer Institute

    RECRUITING

    Portland, Oregon, 97213, United States

  • Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Chelsea)

    RECRUITING

    Chelsea, SW3 6JJ, United Kingdom

  • Royal Marsden NHS Foundation Trust, Royal Marsden Hospital (RMH)/Sutton

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Rutgers Cancer Institute

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START - Midwest Cancer Research Center

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Madrid CIOCC, Hospital Universitario HM Sanchinarro

    RECRUITING

    Madrid, 28050, Spain

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

    Contact Email: •••••@•••••

  • Saint Luke's Cancer Institute

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital - Yonsei Cancer Center

    RECRUITING

    Seoul, 03722, South Korea

  • St. Vincent's University Hospital

    RECRUITING

    Dublin, D04 T6F4, Ireland

  • The START center Dublin

    RECRUITING

    Dublin, Dublin, D07 R2WY, Ireland

  • UCSD Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90089, United States

  • University Hospital Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Vanderbilt Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.