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
Start Date
9/2/2025
Completion Date
11/1/2029
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Telisotuzumab Adizutecan
Standard of Care
Conditions
Locations
Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621
Huntsville, Alabama 35805
United States
Providence Medical Foundation - Fullerton /ID# 274207
Fullerton, California 92835-3826
United States
USC Norris Comprehensive Cancer Center /ID# 274550
Los Angeles, California 90033
United States
Mayo Clinic Hospital Jacksonville /ID# 274472
Jacksonville, Florida 32224
United States
Moffitt Cancer Center /ID# 274372
Tampa, Florida 33612
United States
University of Chicago Medical Center /ID# 274742
Chicago, Illinois 60637
United States
Johns Hopkins Hospital /ID# 275645
Baltimore, Maryland 21287
United States
Massachusetts General Hospital /ID# 273608
Boston, Massachusetts 02114
United States
University of Michigan Health System - Ann Arbor /ID# 273511
Ann Arbor, Michigan 48109
United States
Scri Minnesota Oncology Hematology, P.A. /ID# 275149
Minneapolis, Minnesota 55404
United States
Mayo Clinic-Rochester /ID# 273508
Rochester, Minnesota 55905
United States
Northwell Health Center for Advanced Medicine. /ID# 275331
Lake Success, New York 11042
United States
Duke University Medical Center /ID# 279457
Durham, North Carolina 27710
United States
Northwest Cancer Specialists /ID# 275151
Portland, Oregon 97227-1800
United States
Abramson Cancer Center at the University of Pennsylvania /ID# 275407
Philadelphia, Pennsylvania 19104
United States
SCRI Oncology Partners /ID# 274522
Nashville, Tennessee 37203
United States
Texas Oncology - Central/South Texas /ID# 275154
Austin, Texas 78705
United States
The Center For Cancer And Blood Disorders /ID# 278512
Fort Worth, Texas 76104
United States
Texas Oncology-Grapevine /ID# 275155
Grapevine, Texas 76051
United States
The University of Texas MD Anderson Cancer Center /ID# 273539
Houston, Texas 77030
United States
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586
Fairfax, Virginia 22031
United States
Virginia Cancer Specialists - Fairfax /ID# 274339
Fairfax, Virginia 22031
United States
Cliniques Universitaires UCL Saint-Luc /ID# 278669
Brussels, Brussels Capital 1200
Belgium
Universitair Ziekenhuis Leuven /ID# 278668
Leuven, Vlaams-Brabant 3000
Belgium
CHU de Liege /ID# 278857
Liège, 4000
Belgium
Aarhus Universitetshospital - Skejby /ID# 274498
Aarhus, Central Jutland 8200
Denmark
Odense University Hospital /ID# 274970
Odense C, Region Syddanmark 5000
Denmark
Vejle Sygehus /ID# 274368
Vejle, Region Syddanmark 7100
Denmark
Azienda Ospedaliero Universitaria Careggi /ID# 273604
Florence, Firenze 50134
Italy
IRCCS Istituto Clinico Humanitas /ID# 273566
Rozzano, Lombardy 20089
Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 273540
Naples, Napoli 80138
Italy
Aichi Cancer Center /ID# 275479
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East /ID# 273614
Kashiwa-shi, Chiba 277-8577
Japan
Kyushu University Hospital /ID# 273710
Fukuoka, Fukuoka 812-8582
Japan
Gifu University Hospital /ID# 274179
Gifu, Gifu 501-1194
Japan
Yokohama City University Medical Center /ID# 273657
Yokohama, Kanagawa 232-0024
Japan
Tohoku University Hospital /ID# 275481
Sendai, Miyagi 980-8574
Japan
National Hospital Organization Osaka National Hospital /ID# 274306
Osaka, Osaka 540-0006
Japan
Shizuoka Cancer Center /ID# 275480
Sunto-gun, Shizuoka 411-8777
Japan
Seoul National University Hospital /ID# 274451
Seoul, Seoul Teugbyeolsi 03080
South Korea
Asan Medical Center /ID# 274454
Seoul, Seoul Teugbyeolsi 05505
South Korea
Samsung Medical Center /ID# 274452
Seoul, Seoul Teugbyeolsi 06351
South Korea
Hospital Universitario Virgen del Rocio /ID# 273720
Seville, Sevilla 41013
Spain
Hospital Universitario La Paz /ID# 273718
Madrid, 28046
Spain
Hospital Universitario de Salamanca /ID# 273719
Salamanca, 37007
Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 273745
Kaohsiung City, 807
Taiwan
China Medical University Hospital /ID# 274644
Taichung, 40447
Taiwan
National Taiwan University Hospital /ID# 273580
Taipei, 100
Taiwan