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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Aman
Opneja
Protocol Number
PRO00119303
NCT ID
NCT07023289
Phase
II
Enrollment Status
Pending Open to Enrollment