AMG 355_20220028 (Solid Tumors)
What is the 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.
What is the Condition Being Studied?
Metastatic, Advanced Solid Tumor Cancers
Who Can Participate in the Study?
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
For more information, contact the study team at ryan.woelfel@duke.edu.
Age Group
Adults
What is Involved?
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.
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
Instructor in the Department of Medicine
Protocol Number
IRB:
PRO00116617
NCT:
NCT06131398
Phase
Phase
I
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
NEW