ABBV-400 + fluororuracil, folinic acid, and bevacizumab for colorectal cancer (M24-311) - 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 treating colorectal cancer when it is combined with the following standard-of-care drugs: 5-fluorouracil, folinic acid, and bevacizumab. We are also trying to find the best dose and frequency of ABBV-400 to use.
What is the Condition Being Studied?
Colorectal Cancer
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with metastatic colorectal cancer
- Had 1 prior line of standard therapy that was not successful
For more information about who can join this study, contact the study team at 919-668-1861.
Age Group
Adults
What is Involved?
If you choose to join this study, you will:
- Get IV infusions of 5-fluorouracil, folinic acid, and bevacizumab every 2 weeks
- Get IV infusions of the study drug every 2 or 4 weeks
- Have blood draws and give urine samples
- Have regular CT or MRI scans
Some participants who join will get IV infusions of a drug called irinotecan every 2 weeks instead of the study drug. This is a standard-of-care drug. You will know if you are assigned to this group.
Study Details
Full Title
[M24-311] A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination with Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects with Unresectable Metastatic Colorectal Cancer
Principal Investigator
Medical Oncologist
Protocol Number
IRB:
PRO00113954
NCT:
NCT06107413
Phase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Call 919-668-1861
or email gi-oncology-cru@dm.duke.edu