Purpose of this Study
We are doing this study to find out if an experimental drug called AMG 355 (the study drug) is a safe and effective option for people who have a solid tumor form of cancer that is metastatic (spread to surrounding tissues in the body). We want to know how well the study drug works on its own or in combination with an approved cancer drug called pembrolizumab.
Who Can Participate?
Eligibility
Adults ages 18+ who have one of the following forms of cancer that has come back after treatment or did not respond to standard therapy:
- Non-small cell lung cancer
- Colorectal cancer
- Gastric cancer
- Melanoma
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
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group A: If you are in this group, you will take only the study drug while you are in the study.
- Group B: If you are in this group, you will take the study drug in combination with pembrolizumab while you are in the study.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
Principal Investigator
Christopher
Hoimes
Protocol Number
PRO00116617
NCT ID
NCT06131398
Phase
I
Enrollment Status
Pending Open to Enrollment