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Phase 1Recruiting

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

Sponsored by Iambic Therapeutics, Inc

About this study

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.

This is a Phase 1/1b open-label, multi-center study, designed to evaluate IAM1363 in participants with advanced cancers that harbor HER2 alterations. This study consists of the following 4 parts: * Part 1 (Monotherapy Dose Escalation) * Part 2 (Dose Optimization) * Part 3 (Dose Expansion) * Part 4 (Combination Cohorts) Part 1 will enroll participants with a confirmed, relapsed/refractory malignancy with documented diagnosis of HER2 alterations including participants with brain metastases. Once a provisional maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) has been determined, Part 2 will enroll additional cohorts to optimize dose selection and to further evaluate the safety and preliminary efficacy of IAM1363. Following completion of Dose Optimization, Part 3 will be opened …

Where this study is enrolling (3)

  • University of Chicago

    Chicago, Illinois

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  • MD Anderson Cancer Center - University of Texas

    Houston, Texas

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  • START Mountain Region

    West Valley City, Utah

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Who can participate

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

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.