ABBV-400 vs. trifluridine-tipiracil + bevacizumab in colorectal cancer - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called ABBV-400 (the study drug) is a safe and effective option for people with colorectal cancer. We want to compare how well the study drug works versus the standard treatment of LONSURF ([Trifluridine and Tipiracil] plus Bevacizumab) for patients with c-Met overexpressed, uncontrolled metastatic colorectal cancer.
What is the Condition Being Studied?
Metastatic Colorectal Cancer
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with metastatic colorectal cancer
- Have high c-Met expression
- Do not have any blood clotting disorder(s)
- Are able to carry out all activities of daily living without assistance
For more information, contact the study team at dana.a.warren@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 1: If you are in this group, you will get the study drug.
- Group 2: If you are in this group, you will get LONSURF.
You will continue to take your assigned study regimen for as long as you and your doctor believe that you are getting a positive benefit.
Study Details
Full Title
AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer (M24-064)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:
PRO00116722
NCT:
NCT06614192
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment