A Phase 1/1b Study of IAM1363 in HER2 Cancers
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 9, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Iambic Therapeutics, Inc
- Interventions being studied
- Drug: IAM1363
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCSD Moores Cancer CenterLa Jolla, California
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- University of Colorado Cancer CenterAurora, Colorado
- University of MiamiMiami, Florida
- Comprehensive Hematology OncologySt. Petersburg, Florida
- University of ChicagoChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Henry Ford Cancer InstituteDetroit, Michigan
- START - Midwest Cancer Research CenterGrand Rapids, Michigan
- Saint Luke's Cancer InstituteKansas City, Missouri
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 9, 2026. Always confirm current availability with the study team.