A Phase 1/1b Study of IAM1363 in Patients with Advanced Cancers Harboring HER2 Alterations

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Trial Details

Sponsor: Iambic Therapeutics, Inc (industry)

Phase: 1

Start date: March 25, 2024

Planned enrollment: 243

Trial ID: NCT06253871
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: IAM1363 (ENT-H1, IAM-H1)

TrialFetch AI Analysis

Goal: Determine the safety, pharmacokinetics, appropriate dose, and preliminary antitumor activity of IAM1363 in advanced HER2-altered cancers, including activity against brain metastases.

Patients: Adults with relapsed or refractory HER2-altered malignancies whose disease progressed after, or who could not tolerate, their last systemic therapy. Patients need measurable disease, ECOG performance status 0–1, adequate organ function, and LVEF ≥50%. Patients with brain metastases may enroll unless they require immediate local therapy.

Design: Open-label, multicenter, nonrandomized phase 1/1b study with three sequential parts: monotherapy dose escalation, dose optimization, and tumor-specific cohorts evaluated using a Simon two-stage minimax design.

Treatments: IAM1363 capsules are taken orally once or twice daily in 21-day cycles. IAM1363 is an investigational, irreversible HER2 inhibitor active against wild-type HER2 and several HER2 mutants; it is designed to penetrate the brain and spare EGFR, although clinical advantages of those properties remain unproven. In an early report of 24 treated patients, investigators described three ongoing RECIST partial responses in extracranial disease and one RANO-BM partial response in brain metastases; these small, uncontrolled findings do not establish efficacy.

Outcomes: Parts 1 and 2 primarily assess dose-limiting toxicities, adverse events, and pharmacokinetics, including AUC, Cmax, and Tmax. Part 3 primarily measures confirmed objective response by RECIST v1.1 and confirmed CNS response by RANO-BM. Secondary measures include laboratory and ECG abnormalities, response and disease-control measures, duration of response, progression-free and overall survival, CNS activity, and additional safety and pharmacokinetic assessments.

Burden on patient: Likely moderate to high, especially during dose escalation and optimization: early-cycle pharmacokinetic blood sampling and close toxicity monitoring add visits and testing to routine cancer care. Oral dosing reduces treatment-center time, but patients also need ongoing laboratory and cardiac assessments and imaging to evaluate systemic and, where relevant, CNS disease. The schedule and any biopsy requirements are not specified.

Last updated: Sep 2026

Eligibility More information

Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.

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Sites (48)

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Centre Georges François Leclerc

Dijon, 21079, France

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Status: Recruiting

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

Toulouse, 31059, France

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Status: Recruiting

Institut de Cancerologie de l'Ouest

Saint-Herblain, 44805, France

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Status: Recruiting

Cork University Hospital, Wilton

Cork, T12DC4A, Ireland

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St. Vincent's University Hospital

Dublin, D04 T6F4, Ireland

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The START center Dublin

Dublin, Dublin, D07 R2WY, Ireland

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Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3

Florence, 50134, Italy

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Istituto Europeo di Oncologia (IEO)

Milan, 20141, Italy

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Netherlands Cancer Institute-Antoni van Leeuwenhoek

Amsterdam, 1066CX, Netherlands

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Asan Medical Center

Seoul, 05505, South Korea

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Samsung Medical Center

Seoul, 06351, South Korea

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Seoul National University Hospital

Seoul, 03080, South Korea

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Severance Hospital - Yonsei Cancer Center

Seoul, 03722, South Korea

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Hospital Clinico Universitario de Valencia (INCLIVA)

Valencia, 46010, Spain

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Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

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Hospital Universitario Vall dHebron

Barcelona, 08035, Spain

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Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

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START Madrid CIOCC, Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

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Oxford University Hospitals NHS Foundation Trust Churchill Hospital

Oxford, OX3 7LE, United Kingdom

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UCSD Moores Cancer Center

La Jolla, California, 92093, United States

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USC Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

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University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

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Comprehensive Hematology Oncology

St. Petersburg, Florida, 33709, United States

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University of Miami

Miami, Florida, 33136, United States

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University of Chicago

Chicago, Illinois, 60637, United States

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Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

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Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

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Henry Ford Cancer Institute

Detroit, Michigan, 48202, United States

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START - Midwest Cancer Research Center

Grand Rapids, Michigan, 49546, United States

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University of Michigan

Ann Arbor, Michigan, 48109, United States

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Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

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Washington University School of Medicine

St Louis, Missouri, 63110, United States

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RUTGERS Cancer Institute

New Brunswick, New Jersey, 08901, United States

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Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

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Duke Cancer Institute

Durham, North Carolina, 27710, United States

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Cleveland Clinic

Cleveland, Ohio, 44195, United States

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University Hospital Cleveland Medical Center

Cleveland, Ohio, 44106, United States

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OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

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Providence Cancer Institute

Portland, Oregon, 97213, United States

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SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

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Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37232, United States

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MD Anderson Cancer Center - University of Texas

Houston, Texas, 77030, United States

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Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

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NEXT Oncology - Austin

Austin, Texas, 78758, United States

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NEXT Oncology - Dallas

Dallas, Texas, 75039, United States

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START Mountain Region

West Valley City, Utah, 84119, United States

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NEXT Oncology - Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

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Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

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Status: Recruiting

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