RecruitingPhase 1NCT06253871

A Phase 1/1b Study of IAM1363 in HER2 Cancers

A Phase 1/1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations

Sponsor

Iambic Therapeutics, Inc

Enrollment

383 participants

Start Date

Mar 25, 2024

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer HER2 + Breast Cancer HER2 Mutation-Related Tumors HER2 Brain Metastases From Solid Tumors Brain Metastases From HER2 and Breast Cancer CNS Metastases HER2-Positive Solid Tumors NSCLC (Non-small Cell Lung Cancer)HER2-positive Bladder Cancer HER2-positive Colorectal Cancer HER2 + Gastric Cancer HER2-positive Gastroesophageal Cancer

Summary

This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial tests a new investigational drug called IAM1363 in patients with HER2-altered cancers — cancers that have too much or a mutated form of the HER2 protein. HER2 alterations are found in breast, stomach, lung, and other cancers. This early-phase trial mainly assesses safety and the right dosing of IAM1363. **You may be eligible if...** - You are 18 or older with a confirmed HER2-altered cancer that has relapsed or has not responded to prior treatment - You have measurable disease on imaging - You are in good health (ECOG performance status 0–1) - Your heart pumping function (LVEF) is at least 50% - Your blood counts, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - You have significant heart disease - You have uncontrolled HIV, hepatitis A, B, or C - You have severe nausea or vomiting that cannot be controlled - You have poorly controlled other medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIAM1363

IAM1363 monotherapy OR IAM1363 in combination with capecitabine + trastuzumab OR IAM1363 in combination with capecitabine + zanidatamab OR IAM1363 in combination with T-Dxd OR IAM1363 in combination with pembrolizumab +/- carboplatin and pemetrexed

Locations(48)

UCSD Moores Cancer Center

La Jolla, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

University of Miami

Miami, Florida, United States

Comprehensive Hematology Oncology

St. Petersburg, Florida, United States

University of Chicago

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Cancer Institute

Detroit, Michigan, United States

START - Midwest Cancer Research Center

Grand Rapids, Michigan, United States

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

RUTGERS Cancer Institute

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

University Hospital Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Providence Cancer Institute

Portland, Oregon, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

NEXT Oncology - Austin

Austin, Texas, United States

NEXT Oncology - Dallas

Dallas, Texas, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

MD Anderson Cancer Center - University of Texas

Houston, Texas, United States

START Mountain Region

West Valley City, Utah, United States

NEXT Oncology - Virginia Cancer Specialists

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Centre Georges François Leclerc

Dijon, France

Institut de Cancerologie de l'Ouest

Saint-Herblain, France

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

Toulouse, France

The START center Dublin

Dublin, Dublin, Ireland

Cork University Hospital, Wilton

Cork, Ireland

St. Vincent's University Hospital

Dublin, Ireland

Azienda Ospedaliero Universitaria Careggi - Largo Giovanni Alessandro Brambilla 3

Florence, Italy

Istituto Europeo di Oncologia (IEO)

Milan, Italy

Netherlands Cancer Institute-Antoni van Leeuwenhoek

Amsterdam, Netherlands

Seoul National University Hospital

Seoul, South Korea

Severance Hospital - Yonsei Cancer Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitario Vall dHebron

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

START Madrid CIOCC, Hospital Universitario HM Sanchinarro

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia (INCLIVA)

Valencia, Spain

Oxford University Hospitals NHS Foundation Trust Churchill Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06253871

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A Phase 1/1b Study of IAM1363 in HER2 Cancers

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(48)

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