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

Description

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.

Interventions

• Telisotuzumab Adizutecan (Drug)
  Intravenous (IV) Infusion
• Standard of Care (Drug)
  Standard of care treatment based on investigator's judgement to the active surveillance.

Eligibility criteria

Conditions

Locations

• Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621 — Huntsville, Alabama, United States
• Providence Medical Foundation - Fullerton /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
• Massachusetts General Hospital /ID# 273608 — Boston, Massachusetts, United States
• University of Michigan Health System - Ann Arbor /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
• Duke University Medical Center /ID# 279457 — Durham, North Carolina, United States
• Northwest Cancer Specialists /ID# 275151 — Portland, Oregon, United States
• University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 275407 — Philadelphia, Pennsylvania, 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
• Cliniques Universitaires UCL Saint-Luc /ID# 278669 — Brussels, Brussels Capital, Belgium
• Universitair Ziekenhuis Leuven /ID# 278668 — Leuven, Vlaams-Brabant, Belgium
• CHU de Liege /ID# 278857 — Liège, Belgium
• 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
• National Cancer Center Hospital East /ID# 273614 — Kashiwa-shi, Chiba, 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