Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called IAM1363 (the study drug) for people who have advanced cancers harboring HER2 alterations.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have a relapsed/refractory form of cancer that does not respond to standard therapy, or no standard therapy exists that is likely to provide clinical benefit
- Have a left ventricular ejection fraction (LVEF) of at least 50%
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is being conducted in 3 parts:
- Part 1 is called Dose Escalation, and about 126 participants will be enrolled in this part of the study. This part of the study will help us find out what doses of the study drug have the potential to be safe and beneficial.
- Part 2 is called Dose Optimization, and this part of the study will enroll about 40 participants. This part of the study will help us find out what dose of the study drug seems to be ideal.
- Part 3 will test the dose of selected in Part 2 in patients with specific types of cancer to see if it is effective. About 77 participants will be enrolled.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1/1b Study of IAM1363 in Participants with Advanced Cancers Harboring HER2 Alterations
Principal Investigator
Laura
Alder
Protocol Number
PRO00117953
NCT ID
NCT06253871
Phase
I
Enrollment Status
Open to Enrollment