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

NCT06253871

This study is recruiting at 29 US sites in 19 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • HER2 Mutation-Related Tumors
  • HER2
  • HER2-positive Breast Cancer
  • HER2 + Breast Cancer
  • 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

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Iambic Therapeutics, Inc
Last updated on ClinicalTrials.gov
September 9, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 2

  • UCSD Moores Cancer Center · La Jolla, CA
  • USC Norris Comprehensive Cancer Center · Los Angeles, CA

Colorado · 1

  • University of Colorado Cancer Center · Aurora, CO

Florida · 2

  • University of Miami · Miami, FL
  • Comprehensive Hematology Oncology · St. Petersburg, FL

Illinois · 1

  • University of Chicago · Chicago, IL

Massachusetts · 2

  • Dana Farber Cancer Institute · Boston, MA
  • Massachusetts General Hospital · Boston, MA

Michigan · 3

  • University of Michigan · Ann Arbor, MI
  • Henry Ford Cancer Institute · Detroit, MI
  • START - Midwest Cancer Research Center · Grand Rapids, MI

Missouri · 2

  • Saint Luke's Cancer Institute · Kansas City, MO
  • Washington University School of Medicine · St Louis, MO

New Hampshire · 1

  • Dartmouth Hitchcock Medical · Lebanon, NH

New Jersey · 1

  • Rutgers Cancer Institute · New Brunswick, NJ

New York · 1

  • Icahn School of Medicine at Mount Sinai · New York, NY

North Carolina · 1

  • Duke Cancer Institute · Durham, NC

Ohio · 2

  • Cleveland Clinic · Cleveland, OH
  • University Hospital Cleveland Medical Center · Cleveland, OH

Oklahoma · 1

  • OU Health Stephenson Cancer Center · Oklahoma City, OK

Oregon · 1

  • Providence Cancer Institute · Portland, OR

Tennessee · 2

  • SCRI Oncology Partners · Nashville, TN
  • Vanderbilt Ingram Cancer Center · Nashville, TN

Texas · 3

  • NEXT Oncology - Austin · Austin, TX
  • Mary Crowley Cancer Research · Dallas, TX
  • MD Anderson Cancer Center - University of Texas · Houston, TX

Utah · 1

  • START Mountain Region · West Valley City, UT

Virginia · 1

  • NEXT Oncology - Virginia Cancer Specialists · Fairfax, VA

Washington · 1

  • Fred Hutchinson Cancer Center · Seattle, WA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.