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
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)
2 other identifiers
interventional
140
7 countries
41
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 colorectal-cancer
Started Aug 2025
Typical duration for phase_2 colorectal-cancer
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2025
CompletedFirst Posted
Study publicly available on registry
June 16, 2025
CompletedStudy Start
First participant enrolled
August 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
March 13, 2026
March 1, 2026
4.2 years
June 10, 2025
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with disease free survival (DFS) Event
DFS is defined as the time from randomization to the time of first occurrence of first radiographic recurrence of colorectal cancer (CRC), (either local recurrence or distant metastases) as determined by the investigator, or death from any cause.
Up to Approximately 51 Months
Secondary Outcomes (2)
Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months
6 Months
Overall Survival (OS)
Up to Approximately 51 Months
Study Arms (2)
Telisotuzumab Adizutecan Monotherapy
EXPERIMENTALParticipants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration.
Standard of Care (SOC)
ACTIVE COMPARATORParticipants will receive SOC, during the approximately 51 month study duration.
Interventions
Standard of care treatment based on investigator's judgement to the active surveillance.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (41)
Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621
Huntsville, Alabama, 35805, United States
Providence Medical Foundation /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
University Of Michigan /ID# 273511
Ann Arbor, Michigan, 48109-5000, 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
Northwest Cancer Specialists /ID# 275151
Portland, Oregon, 97227-1800, 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
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
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2025
First Posted
June 16, 2025
Study Start
August 7, 2025
Primary Completion (Estimated)
November 1, 2029
Study Completion (Estimated)
November 1, 2029
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.