A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NCT07023289)
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)
🩺 Plain-English Summary (8th-Grade Level)
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide. In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Who can join: Review the eligibility criteria below.
Location: Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621 — Huntsville, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (48 Sites)
Showing the first 25 of 48 sites.
- Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621 — Huntsville, Alabama
- Providence Medical Foundation - Fullerton /ID# 274207 — Fullerton, California
- USC Norris Comprehensive Cancer Center /ID# 274550 — Los Angeles, California
- Mayo Clinic Hospital Jacksonville /ID# 274472 — Jacksonville, Florida
- Moffitt Cancer Center /ID# 274372 — Tampa, Florida
- University of Chicago Medical Center /ID# 274742 — Chicago, Illinois
- Johns Hopkins Hospital /ID# 275645 — Baltimore, Maryland
- Massachusetts General Hospital /ID# 273608 — Boston, Massachusetts
- University of Michigan Health System - Ann Arbor /ID# 273511 — Ann Arbor, Michigan
- Scri Minnesota Oncology Hematology, P.A. /ID# 275149 — Minneapolis, Minnesota
- Mayo Clinic-Rochester /ID# 273508 — Rochester, Minnesota
- Northwell Health Center for Advanced Medicine. /ID# 275331 — Lake Success, New York
- Duke University Medical Center /ID# 279457 — Durham, North Carolina
- Northwest Cancer Specialists /ID# 275151 — Portland, Oregon
- Abramson Cancer Center at the University of Pennsylvania /ID# 275407 — Philadelphia, Pennsylvania
- SCRI Oncology Partners /ID# 274522 — Nashville, Tennessee
- Texas Oncology - Central/South Texas /ID# 275154 — Austin, Texas
- The Center For Cancer And Blood Disorders /ID# 278512 — Fort Worth, Texas
- Texas Oncology-Grapevine /ID# 275155 — Grapevine, Texas
- The University of Texas MD Anderson Cancer Center /ID# 273539 — Houston, Texas
- Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586 — Fairfax, Virginia
- Virginia Cancer Specialists - Fairfax /ID# 274339 — Fairfax, Virginia
- Cliniques Universitaires UCL Saint-Luc /ID# 278669 — Brussels, Brussels Capital
- Universitair Ziekenhuis Leuven /ID# 278668 — Leuven, Vlaams-Brabant
- CHU de Liege /ID# 278857 — Liège,
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.