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A Phase 1/1b Study of IAM1363 in Patients with Advanced Cancers Harboring HER2 Alterations

Primary Investigator
Morikawa, Aki
Status
OPEN TO ACCRUAL
Phase
I
NCT Number
NCT06253871
UM Number
2024.026
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Multi-tumor Experimental Therapeutics
ID (Protocol)
50456
Secondary Protocol No
HUM00250818
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Anus
Brain and Nervous System
Breast
Cervix
Colon
Esophagus
Kidney
Lip, Oral Cavity and Pharynx
Liver
Lung
Melanoma, Skin
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Male Genital
Other Urinary
Prostate
Rectum
Thyroid
Urinary Bladder
Summary
This is a Phase 1/1b open-label, multi-center dose escalation and dose optimization study, designed to evaluate safety and preliminary efficacy of IAM1363 as monotherapy and in combination with trastuzumab in patients with advanced cancers that harbor HER2 alterations.

Eligibility: Inclusion Criteria
  •   Key
  •   * Age >= 18 years
  •   * Have relapsed/refractory HER2-altered malignancy
  •   * Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy
  •   * Have radiographically measurable disease assessable by RECIST v1.1
  •   * Eastern Cooperative Oncology Group (ECOG) performance score 0-1
  •   * Have adequate baseline hematologic, liver and renal function
  •   * Have left ventricular ejection fraction (LVEF) >= 50%
  •   Key
Exclusion Criteria
  •   * Clinically significant cardiac disease
  •   * Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Patients 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
  •   * Patients requiring immediate local therapy for brain metastases