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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 · AbbVie
In plain English
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Official title
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)
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
* Surgical tumor material should be available and must be submitted for Signatera personalized panel and assessment of c-Met protein levels.
* Must have received at least 3 months of platinum-based doublet adjuvant chemotherapy but may not have been treated with topoisomerase inhibitors as part of adjuvant therapy.
* Has no radiographic evidence of disease (NED) confirmed by chest, abdominal, and pelvic computed tomography (CT) scans within 6 weeks prior to Cycle 1 Day 1 (C1D1) dosing.
* Circulating tumor deoxyribonucleic acid (ctDNA) positive after the end of adjuvant therapy and begin the treatment within 6 weeks after ctDNA is confirmed (reported).
* For participants with rectal cancer a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet must have been administered. Please note that short course radiation or long-course chemoradiation does not count towards this 3-month minimum of platinum-doublet perioperative and/or adjuvant therapy.
* For participants with oligometastatic disease a total of at least 3 months of perioperative and/or adjuvant platinum-based doublet therapy must have been administered.
Exclusion Criteria:
* No availability of surgical tissue sample.
* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.
Study design
Enrollment target: 140 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-07
Estimated completion: 2029-11
Last updated: 2026-03-13
Interventions
Drug: Telisotuzumab AdizutecanDrug: Standard of Care
Primary outcomes
- • Percentage of Participants with disease free survival (DFS) Event (Up to Approximately 51 Months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (41)
Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621Recruiting
Huntsville, Alabama, United States
Providence Medical Foundation /ID# 274207Recruiting
Fullerton, California, United States
USC Norris Comprehensive Cancer Center /ID# 274550Recruiting
Los Angeles, California, United States
Mayo Clinic Hospital Jacksonville /ID# 274472Recruiting
Jacksonville, Florida, United States
Moffitt Cancer Center /ID# 274372Recruiting
Tampa, Florida, United States
University of Chicago Medical Center /ID# 274742Recruiting
Chicago, Illinois, United States
Johns Hopkins Hospital /ID# 275645Recruiting
Baltimore, Maryland, United States
University Of Michigan /ID# 273511Recruiting
Ann Arbor, Michigan, United States
Scri Minnesota Oncology Hematology, P.A. /ID# 275149Recruiting
Minneapolis, Minnesota, United States
Mayo Clinic-Rochester /ID# 273508Recruiting
Rochester, Minnesota, United States
Northwell Health Center for Advanced Medicine. /ID# 275331Recruiting
Lake Success, New York, United States
Northwest Cancer Specialists /ID# 275151Recruiting
Portland, Oregon, United States
SCRI Oncology Partners /ID# 274522Recruiting
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas /ID# 275154Recruiting
Austin, Texas, United States
The Center For Cancer And Blood Disorders /ID# 278512Recruiting
Fort Worth, Texas, United States
Texas Oncology-Grapevine /ID# 275155Recruiting
Grapevine, Texas, United States
The University of Texas MD Anderson Cancer Center /ID# 273539Recruiting
Houston, Texas, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586Recruiting
Fairfax, Virginia, United States
Virginia Cancer Specialists - Fairfax /ID# 274339Recruiting
Fairfax, Virginia, United States
Aarhus Universitetshospital - Skejby /ID# 274498Recruiting
Aarhus, Central Jutland, Denmark
Odense University Hospital /ID# 274970Recruiting
Odense C, Region Syddanmark, Denmark
Vejle Sygehus /ID# 274368Recruiting
Vejle, Region Syddanmark, Denmark
Azienda Ospedaliero Universitaria Careggi /ID# 273604Recruiting
Florence, Firenze, Italy
IRCCS Istituto Clinico Humanitas /ID# 273566Recruiting
Rozzano, Lombardy, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273540Recruiting
Naples, Napoli, Italy
Aichi Cancer Center /ID# 275479Recruiting
Nagoya, Aichi-ken, Japan
Kyushu University Hospital /ID# 273710Recruiting
Fukuoka, Fukuoka, Japan
Gifu University Hospital /ID# 274179Recruiting
Gifu, Gifu, Japan
Yokohama City University Medical Center /ID# 273657Recruiting
Yokohama, Kanagawa, Japan
Tohoku University Hospital /ID# 275481Recruiting
Sendai, Miyagi, Japan
National Hospital Organization Osaka National Hospital /ID# 274306Recruiting
Osaka, Osaka, Japan
Shizuoka Cancer Center /ID# 275480Recruiting
Sunto-gun, Shizuoka, Japan
Seoul National University Hospital /ID# 274451Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 274454Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 274452Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario Virgen del Rocio /ID# 273720Recruiting
Seville, Sevilla, Spain
Hospital Universitario La Paz /ID# 273718Recruiting
Madrid, Spain
Hospital Universitario de Salamanca /ID# 273719Recruiting
Salamanca, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745Recruiting
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 274644Recruiting
Taichung, Taiwan
National Taiwan University Hospital /ID# 273580Recruiting
Taipei, Taiwan