Recruiting

Phase 2

Telisotuzumab AdizutecanA 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

Code:

NCT07023289

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telisotuzumab Adizutecan

Standard of Care

Study Details

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.

Conditions

Colorectal Cancer

Study ID

NCT07023289

Start date

Sep 2, 2025

Status verified date

Jul, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Telisotuzumab Adizutecan Monotherapy

Participants will receive telisotuzumab adizutecan dose A as a monotherapy, during the approximately 51 month study duration.

active comparator: Standard of Care (SOC)

Participants will receive SOC, during the approximately 51 month study duration.

Interventions

Telisotuzumab Adizutecan

Intravenous (IV) Infusion

Standard of Care

Standard of care treatment based on investigator's judgement to the active surveillance.

Primary outcome measure

Percentage of Participants with disease free survival (DFS) Event [ Time Frame: Up to Approximately 51 Months ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621

Recruiting

Huntsville, Alabama, United States, 35805

Providence Medical Foundation - Fullerton /ID# 274207

Recruiting

Fullerton, California, United States, 92835-3826

USC Norris Comprehensive Cancer Center /ID# 274550

Recruiting

Los Angeles, California, United States, 90033

Mayo Clinic Hospital Jacksonville /ID# 274472

Recruiting

Jacksonville, Florida, United States, 32224

Moffitt Cancer Center /ID# 274372

Recruiting

Tampa, Florida, United States, 33612

University of Chicago Medical Center /ID# 274742

Recruiting

Chicago, Illinois, United States, 60637

Johns Hopkins Hospital /ID# 275645

Recruiting

Baltimore, Maryland, United States, 21287

Massachusetts General Hospital /ID# 273608

Recruiting

Boston, Massachusetts, United States, 02114

University of Michigan Health System - Ann Arbor /ID# 273511

Recruiting

Ann Arbor, Michigan, United States, 48109

Scri Minnesota Oncology Hematology, P.A. /ID# 275149

Recruiting

Minneapolis, Minnesota, United States, 55404

Mayo Clinic-Rochester /ID# 273508

Recruiting

Rochester, Minnesota, United States, 55905

Northwell Health Center for Advanced Medicine. /ID# 275331

Recruiting

Lake Success, New York, United States, 11042

Duke University Medical Center /ID# 279457

Recruiting

Durham, North Carolina, United States, 27710

Northwest Cancer Specialists /ID# 275151

Recruiting

Portland, Oregon, United States, 97227-1800

Abramson Cancer Center at the University of Pennsylvania /ID# 275407

Recruiting

Philadelphia, Pennsylvania, United States, 19104

SCRI Oncology Partners /ID# 274522

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - Central/South Texas /ID# 275154

Recruiting

Austin, Texas, United States, 78705

The Center For Cancer And Blood Disorders /ID# 278512

Recruiting

Fort Worth, Texas, United States, 76104

Texas Oncology-Grapevine /ID# 275155

Recruiting

Grapevine, Texas, United States, 76051

The University of Texas MD Anderson Cancer Center /ID# 273539

Recruiting

Houston, Texas, United States, 77030

Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Cancer Specialists - Fairfax /ID# 274339

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

AbbVie

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

Colorectal Cancer
Telisotuzumab Adizutecan
ABBV-400, Stand of Care
Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-10.