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

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.

Who Can Participate?

Eligibility

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.

What is Involved?

Description

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

John
Strickler

Protocol Number

PRO00113954

NCT ID

NCT06107413

Phase

II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov