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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests the safety of IAM1363, different doses, and how well it may work. It is for adults with advanced cancer that has changes in HER2 and has come back or has not responded to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have cancer with HER2 changes that has come back or resisted treatment. Some study groups need a central lab test to confirm these changes.
  • Have cancer that grew after the last whole-body cancer treatment, or be unable to tolerate that treatment.
  • Have cancer that can be measured on scans using the study’s rules.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have blood counts, liver function, and kidney function that meet study requirements.
  • Have a heart that pumps out at least 50% of the blood in its main pumping chamber with each beat.
  • Be able to swallow medicine.

Who can't join

  • Have serious heart disease or diabetes that is not controlled.
  • Have HIV, unless it is well controlled. For example, the CD4 immune cell count is above 350 and no virus is detected in the blood.
  • Have active liver disease, including hepatitis A, B, or C.
  • Have problems that prevent enough medicine from being absorbed, such as ongoing nausea and vomiting, poor absorption, a tube draining bile outside the body, or removal of a large part of the small intestine.
  • Have had a solid organ transplant.
  • Have had grade 2 or worse bleeding in the brain or spinal cord, or any such bleeding within 28 days before the first study dose.
  • Have had lung inflammation or scarring called interstitial lung disease that was not caused by infection. Past mild disease, called grade 1, is allowed if it has fully cleared.
  • Need immediate treatment aimed at cancer that has spread to the brain.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (29)

CA

CO

FL

IL

MA

MI

MO

NC

NH

NJ

NY

OH

OK

OR

TN

TX

UT

VA

WA