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
Public ClinicalTrials.gov record NCT07023289. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07023289
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 1, 2025
- Primary completion
- Oct 31, 2029
- Completion
- Oct 31, 2029
- Last update posted
- Jul 9, 2026
2025 – 2029
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07023289, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 9, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07023289 live on ClinicalTrials.gov.