Evaluating IAM1363 for HER2-related cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UCSD Moores Cancer Center
  La Jolla, California, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Comprehensive Hematology Oncology
  St. Petersburg, Florida, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Iambic Therapeutics, Inc., Senior Medical Director
• Email: ClinicalTrials@Iambic.ai
• Phone: 619-330-5499

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.