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