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

Key Who May Qualify: - 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 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% Key Who Should NOT Join This Trial: - Clinically significant cardiac disease - Infection with human weakened immune system 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 Always talk to your doctor about whether this trial is right for you.