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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
Sponsor: AbbVie
Summary
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-08-07
Completion Date
2029-11
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Standard of Care
Standard of care treatment based on investigator's judgement to the active surveillance.
Locations (41)
Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621
Huntsville, Alabama, United States
Providence Medical Foundation /ID# 274207
Fullerton, California, United States
USC Norris Comprehensive Cancer Center /ID# 274550
Los Angeles, California, United States
Mayo Clinic Hospital Jacksonville /ID# 274472
Jacksonville, Florida, United States
Moffitt Cancer Center /ID# 274372
Tampa, Florida, United States
University of Chicago Medical Center /ID# 274742
Chicago, Illinois, United States
Johns Hopkins Hospital /ID# 275645
Baltimore, Maryland, United States
University Of Michigan /ID# 273511
Ann Arbor, Michigan, United States
Scri Minnesota Oncology Hematology, P.A. /ID# 275149
Minneapolis, Minnesota, United States
Mayo Clinic-Rochester /ID# 273508
Rochester, Minnesota, United States
Northwell Health Center for Advanced Medicine. /ID# 275331
Lake Success, New York, United States
Northwest Cancer Specialists /ID# 275151
Portland, Oregon, United States
SCRI Oncology Partners /ID# 274522
Nashville, Tennessee, United States
Texas Oncology - Central/South Texas /ID# 275154
Austin, Texas, United States
The Center For Cancer And Blood Disorders /ID# 278512
Fort Worth, Texas, United States
Texas Oncology-Grapevine /ID# 275155
Grapevine, Texas, United States
The University of Texas MD Anderson Cancer Center /ID# 273539
Houston, Texas, United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586
Fairfax, Virginia, United States
Virginia Cancer Specialists - Fairfax /ID# 274339
Fairfax, Virginia, United States
Aarhus Universitetshospital - Skejby /ID# 274498
Aarhus, Central Jutland, Denmark
Odense University Hospital /ID# 274970
Odense C, Region Syddanmark, Denmark
Vejle Sygehus /ID# 274368
Vejle, Region Syddanmark, Denmark
Azienda Ospedaliero Universitaria Careggi /ID# 273604
Florence, Firenze, Italy
IRCCS Istituto Clinico Humanitas /ID# 273566
Rozzano, Lombardy, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273540
Naples, Napoli, Italy
Aichi Cancer Center /ID# 275479
Nagoya, Aichi-ken, Japan
Kyushu University Hospital /ID# 273710
Fukuoka, Fukuoka, Japan
Gifu University Hospital /ID# 274179
Gifu, Gifu, Japan
Yokohama City University Medical Center /ID# 273657
Yokohama, Kanagawa, Japan
Tohoku University Hospital /ID# 275481
Sendai, Miyagi, Japan
National Hospital Organization Osaka National Hospital /ID# 274306
Osaka, Osaka, Japan
Shizuoka Cancer Center /ID# 275480
Sunto-gun, Shizuoka, Japan
Seoul National University Hospital /ID# 274451
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 274454
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 274452
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario Virgen del Rocio /ID# 273720
Seville, Sevilla, Spain
Hospital Universitario La Paz /ID# 273718
Madrid, Spain
Hospital Universitario de Salamanca /ID# 273719
Salamanca, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745
Kaohsiung City, Taiwan
China Medical University Hospital /ID# 274644
Taichung, Taiwan
National Taiwan University Hospital /ID# 273580
Taipei, Taiwan