A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer

ClinicalTrials.gov ID: NCT07525206

Public ClinicalTrials.gov record NCT07525206. 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.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Oct 27, 2026, 12:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer

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 the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 990 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally. In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 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: NCT07525206
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: AbbVie; Industry
Enrollment: 990 participants

Conditions and interventions

Conditions

Colorectal Cancer

Interventions

Drug

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: May 22, 2026 (Actual)
Primary completion: May 2029 (Estimated)
Completion: Mar 2030 (Estimated)
Last update posted: Oct 19, 2026

2026 – 2030

United States locations

U.S. sites: 18
U.S. states: 17
U.S. cities: 18

Facility	City	State	ZIP	Site status
City Of Hope - Phoenix /ID# 279450	Goodyear	Arizona	85338	Recruiting
Highlands Oncology Group - Springdale /ID# 279444	Springdale	Arkansas	72762	Recruiting
City of Hope National Medical Center /ID# 279449	Duarte	California	91010	Recruiting
Rocky Mountain Cancer Centers - Aurora /ID# 280112	Aurora	Colorado	80012	Recruiting
Yale University School of Medicine /ID# 279373	New Haven	Connecticut	06510	Recruiting
Moffitt Cancer Center /ID# 279325	Tampa	Florida	33612	Recruiting
City Of Hope - Atlanta /ID# 280017	Newnan	Georgia	30265	Recruiting
University of Chicago Medical Center /ID# 279365	Chicago	Illinois	60637	Recruiting
Saint Lukes Hospital of Kansas City /ID# 279513	Kansas City	Missouri	64111	Recruiting
Astera Cancer Care /ID# 279532	East Brunswick	New Jersey	08816-4096	Recruiting
Northwell Health Center for Advanced Medicine. /ID# 279590	Lake Success	New York	11042	Recruiting
Duke University Medical Center /ID# 279322	Durham	North Carolina	27710	Recruiting
Oncology Hematology Care - Blue Ash /ID# 280143	Cincinnati	Ohio	45252	Recruiting
Compass Oncology - Rose Quarter /ID# 280127	Portland	Oregon	97227	Recruiting
Texas Oncology - Abilene - Antilley Road /ID# 280120	Abilene	Texas	79606	Recruiting
The University of Texas MD Anderson Cancer Center /ID# 279865	Houston	Texas	77030	Recruiting
Blue Ridge Cancer Care - Blacksburg /ID# 280115	Blacksburg	Virginia	24060	Recruiting
University Of Washington /ID# 281451	Seattle	Washington	98109	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 70 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07525206, 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 Oct 19, 2026 · Synced Oct 27, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07525206 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →