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

• IAM1363 is a HER2 inhibitor

In this study, the sponsor and investigators want to learn:

• How much of the study drug can be given with an acceptable level of side effects
• The effects of the study drug (good and bad)
• How much of the study drug is absorbed into the blood and how fast it is removed

This is a dose escalation/optimization study and will be conducted in 3 Parts. Part 1 is Dose Escalation, which means that the amount of the study   given will be increased in each group of research participants, to find the most appropriate dose for further study.  In the dose optimization part of the study, Part 2, a larger number of people receive the study drug dose determined to be appropriate in the dose escalation part of the study. In Part 3, the study drug dose determined to be appropriate in the previous parts of the study will be observed in those with specific types of cancer.

The dose of the study   you receive will be determined when you enter the study. Part 1 is the only part of the study that is enrolling as of now.

The study regimen will be given in cycles. Each cycle is 21 days. You will receive the study every day by mouth. On Cycle 1 Day 1, you will take your first dose at the clinic. For some visits, you will have to take your study drug at the clinic. On these days, you will need to fast overnight and continue to fast for at least one hour after taking the study drug. On most days, you will take your study drug at home, as directed by the study doctor. If you forget to take your dose, you may take it for up to 12 hours after the scheduled time; if it is more than 12 hours late, you should skip that dose.