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

IAM1363-01

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.

2024-03-25

2028-04-01

2028-04-01

Recruiting

Early phase I

287

Key Inclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 287, 'type': 'ESTIMATED'}}

2024-05-01