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NCT07023289PHASE2Recruiting

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

AbbVie

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

Inclusion Criteria: * Has histologically or cytologically confirmed adenocarcinoma of the colon or rectum. * Surgical tumor material should be available for Signatera ctDNA personalized panel design. * Must have received at least 3 months of platinum-based doublet adjuvant and/or neoadjuvant 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 within 1 year either after the end of adjuvant therapy or after tumor resection in subjects who are receiving neoadjuvant therapy and begin treatment within 6 weeks after ctDNA positivity 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. 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.

Interventions

DRUG

Telisotuzumab Adizutecan

DRUG

Standard of Care

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Conditions

Colorectal Cancer

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