ABBV-400 Monotherapy to the Current SOC in ctDNA positive CRC and NED (M24-534)

What is the Purpose of this Study?

People in this study will be in one of two groups. One group will get a medicine called ABBV-400 through an IV every 21 days. The other group will not get medicine but will have blood tests for cancer DNA and imaging scans to check for cancer.

What is the Condition Being Studied?

This study is for people who had colon or rectal cancer (called CRC) and already finished extra treatment after surgery, called adjuvant therapy. These people have a blood test that shows cancer DNA (called ctDNA), but their scans do not show any cancer.

Who Can Participate in the Study?

The person must be at least 18 years old. They have a type of cancer called oligometastatic, which is in stage II, III, or IVa. Right now, there are no signs of cancer showing up on their scans.

Age Group
Adults

What is Involved?

The purpose of this study is to find out if a medicine called telisotuzumab adizutecan, also called ABBV-400, can help stop cancer from coming back and maybe even cure people with colorectal cancer. This study is for people who had surgery and chemotherapy and still have cancer DNA in their blood after treatment.

Study Details

Full Title
Colorectal Cancer: A Phase 2, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects with Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED)
Principal Investigator
Assistant Professor of Medicine
Protocol Number
IRB: PRO00119303
NCT: NCT07023289
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF