RecruitingInterventionalPhase 2

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)

NCT ID: NCT07023289Sponsor: AbbVieLast updated: 2026-06-02

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.

Arms & interventions

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

Outcome measures

Primary

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.
Time frame: Up to Approximately 51 Months

Secondary

Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Clearance at 6 months
Time frame: 6 Months
Overall Survival (OS)
Time frame: Up to Approximately 51 Months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (22)

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

Huntsville, Alabama, 35805

Recruiting

Providence Medical Foundation - Fullerton /ID# 274207

Fullerton, California, 92835-3826

Recruiting

USC Norris Comprehensive Cancer Center /ID# 274550

Los Angeles, California, 90033

Recruiting

Mayo Clinic Hospital Jacksonville /ID# 274472

Jacksonville, Florida, 32224

Recruiting

Moffitt Cancer Center /ID# 274372

Tampa, Florida, 33612

Recruiting

University of Chicago Medical Center /ID# 274742

Chicago, Illinois, 60637

Recruiting

Johns Hopkins Hospital /ID# 275645

Baltimore, Maryland, 21287

Recruiting

Massachusetts General Hospital /ID# 273608

Boston, Massachusetts, 02114

Recruiting

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

Ann Arbor, Michigan, 48109

Recruiting

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

Minneapolis, Minnesota, 55404

Recruiting

Mayo Clinic-Rochester /ID# 273508

Rochester, Minnesota, 55905

Recruiting

Northwell Health Center for Advanced Medicine. /ID# 275331

Lake Success, New York, 11042

Recruiting

Duke University Medical Center /ID# 279457

Durham, North Carolina, 27710

Recruiting

Northwest Cancer Specialists /ID# 275151

Portland, Oregon, 97227-1800

Recruiting

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

Philadelphia, Pennsylvania, 19104

Recruiting

SCRI Oncology Partners /ID# 274522

Nashville, Tennessee, 37203

Recruiting

Texas Oncology - Central/South Texas /ID# 275154

Austin, Texas, 78705

Recruiting

The Center For Cancer And Blood Disorders /ID# 278512

Fort Worth, Texas, 76104

Recruiting

Texas Oncology-Grapevine /ID# 275155

Grapevine, Texas, 76051

Recruiting

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

Houston, Texas, 77030

Recruiting

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

Fairfax, Virginia, 22031

Recruiting

Virginia Cancer Specialists - Fairfax /ID# 274339

Fairfax, Virginia, 22031

Recruiting