ABBV-400 + fluororuracil, folinic acid, and bevacizumab for colorectal cancer (M24-311) - Clinical Trial

or email

gi-oncology-cru@dm.duke.edu

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