Tests IAM1363 in adults with advanced cancers that have HER2 changes
Tests IAM1363 for safety and dosing in adults with advanced HER2-altered cancers.
Plain-language title generated from the registry record
Registry title: A Phase 1/1b Study of IAM1363 in HER2 Cancers
Key facts
- Where
- Ann Arbor, Aurora, Austin, Boston, Chicago, Cleveland, Dallas, Detroit, Durham, Fairfax, Grand Rapids, Houston, Kansas City, La Jolla, Lebanon, Los Angeles, Miami, Nashville, New Brunswick, New York, Oklahoma City, Portland, Seattle, St Louis, St. Petersburg, and West Valley City, United StatesSee the 29 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an advanced cancer that has a HER2 change, has come back or not responded to treatment, and can be measured on scans.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Advanced cancer with a HER2 change that came back or did not respond to treatment. The disease must be measurable on scans (RECIST v1.1 and/or RANO-BM).
- Earlier treatment
- The disease must have grown after the last systemic therapy, or the person could not tolerate that therapy.
- Biomarker or test result
- A HER2 change. For some groups, it must be confirmed by central testing before joining.
Main reasons for not taking part
- Clinically significant heart disease
- Active liver disease, including hepatitis A, B or C
- Uncontrolled diabetes
- History of solid organ transplantation
- Brain metastases that need immediate local therapy
Read by machine on 9 November 2026.
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- University of Colorado Cancer CenterAurora, United StatesTaking people
- NEXT Oncology - AustinAustin, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- University of ChicagoChicago, United StatesTaking people
- Cleveland ClinicCleveland, United StatesTaking people
- University Hospital Cleveland Medical CenterCleveland, United StatesTaking people
- Mary Crowley Cancer ResearchDallas, United StatesTaking people
- Henry Ford Cancer InstituteDetroit, United StatesTaking people
- Duke Cancer InstituteDurham, United StatesTaking people
- NEXT Oncology - Virginia Cancer SpecialistsFairfax, United StatesTaking people
- START - Midwest Cancer Research CenterGrand Rapids, United StatesTaking people
- MD Anderson Cancer Center - University of TexasHouston, United StatesTaking people
- Saint Luke's Cancer InstituteKansas City, United StatesTaking people
- UCSD Moores Cancer CenterLa Jolla, United StatesTaking people
- Dartmouth Hitchcock MedicalLebanon, United StatesTaking people
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
- University of MiamiMiami, United StatesTaking people
- SCRI Oncology PartnersNashville, United StatesTaking people
- Vanderbilt-Ingram Cancer CenterNashville, United StatesTaking people
- Rutgers Cancer InstituteNew Brunswick, United StatesTaking people
- Icahn School of Medicine at Mount SinaiNew York, United StatesTaking people
- OU Health Stephenson Cancer CenterOklahoma City, United StatesTaking people
- Providence Cancer InstitutePortland, United StatesTaking people
- Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- Comprehensive Hematology OncologySt. Petersburg, United StatesTaking people
- START Mountain RegionWest Valley City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Iambic Therapeutics, Inc
- Trial code
- NCT06253871
- Record updated
- 9 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 1/1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations
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.
Inclusion: 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.
Exclusion: Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption; 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; 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; Uncontrolled diabetes; History of solid organ transplantation.