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Evaluating IAM1363 for HER2-related cancers

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

Phase 1 Interventional Iambic Therapeutics, Inc · NCT06253871

This study is testing a new treatment called IAM1363 to see if it can help people with advanced cancers that have changes in the HER2 gene.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment383 (estimated)
Ages18 Years and up
SexAll
SponsorIambic Therapeutics, Inc Industry-sponsored
Locations48 sites (La Jolla, California and 47 other locations)
Trial IDNCT06253871 on ClinicalTrials.gov

What this trial studies

This Phase 1/1b open-label, multi-center study aims to assess the safety and preliminary efficacy of IAM1363 in patients with advanced cancers that have HER2 alterations. The study consists of three parts: a monotherapy dose escalation to determine the maximum tolerated dose, a dose optimization phase to refine dosing, and a Simon 2-Stage evaluation for tumor-specific cohorts. Participants must have relapsed or refractory HER2-altered malignancies, including those with brain metastases, and will be monitored for disease progression and treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory HER2-altered malignancies.

Not a fit: Patients with clinically significant cardiac disease or uncontrolled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with HER2-related cancers.

How similar studies have performed: Other studies targeting HER2 alterations have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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

Where this trial is running

La Jolla, California and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HER2 Mutation-Related TumorsHER2HER2-positive Breast CancerHER2 + Breast CancerBrain Metastases From Solid TumorsBrain Metastases From HER2 and Breast CancerCNS MetastasesHER2-Positive Solid Tumors
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.