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
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
- Colorectal Cancer
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- AbbVie
- Enrolment target
- 990
- Started
- 22 May 2026
- Main results due
- May 2029
- Study sites
- 83
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)/ Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator. * Life expectancy \>= 12 weeks per investigator assessment Exclusion Criteria: * Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any Top-1 inhibitor ADC. * History of intolerance, allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil. This also includes patients with known rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. * History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies. * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(83)
City Of Hope - Phoenix /ID# 279450
Goodyear, Arizona, United States
Recruiting
Highlands Oncology Group - Springdale /ID# 279444
Springdale, Arkansas, United States
Recruiting
City of Hope National Medical Center /ID# 279449
Duarte, California, United States
Recruiting
Rocky Mountain Cancer Centers - Aurora /ID# 280112
Aurora, Colorado, United States
Recruiting
Yale University School of Medicine /ID# 279373
New Haven, Connecticut, United States
Recruiting
Moffitt Cancer Center /ID# 279325
Tampa, Florida, United States
Recruiting
City Of Hope - Atlanta /ID# 280017
Newnan, Georgia, United States
Recruiting
University of Chicago Medical Center /ID# 279365
Chicago, Illinois, United States
Recruiting
Saint Lukes Hospital of Kansas City /ID# 279513
Kansas City, Missouri, United States
Recruiting
Astera Cancer Care /ID# 279532
East Brunswick, New Jersey, United States
Recruiting
Northwell Health Center for Advanced Medicine. /ID# 279590
Lake Success, New York, United States
Recruiting
Duke University Medical Center /ID# 279322
Durham, North Carolina, United States
Recruiting
Oncology Hematology Care - Blue Ash /ID# 280143
Cincinnati, Ohio, United States
Recruiting
Compass Oncology - Rose Quarter /ID# 280127
Portland, Oregon, United States
Recruiting
Texas Oncology - Abilene - Antilley Road /ID# 280120
Abilene, Texas, United States
Recruiting
The University of Texas MD Anderson Cancer Center /ID# 279865
Houston, Texas, United States
Recruiting
Blue Ridge Cancer Care - Blacksburg /ID# 280115
Blacksburg, Virginia, United States
Recruiting
University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451
Seattle, Washington, United States
Recruiting
Imelda Ziekenhuis /ID# 279333
Bonheiden, Antwerpen, Belgium
Recruiting
Universitair Ziekenhuis Antwerpen /ID# 279334
Edegem, Antwerpen, Belgium
Recruiting
Institut Jules Bordet /ID# 279406
Anderlecht, Brussels Capital, Belgium
Recruiting
Cliniques Universitaires UCL Saint-Luc /ID# 279335
Brussels, Brussels Capital, Belgium
Recruiting
Universitair Ziekenhuis Brussel /ID# 279535
Jette, Brussels Capital, Belgium
Recruiting
Grand Hopital de Charleroi - Les Viviers /ID# 279336
Charleroi, Hainaut, Belgium
Recruiting
Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 280014
Yvoir, Namur, Belgium
Recruiting
AZ Maria Middelares /ID# 280141
Ghent, Oost-Vlaanderen, Belgium
Recruiting
Universitair Ziekenhuis Leuven /ID# 279330
Leuven, Vlaams-Brabant, Belgium
Recruiting
AZ-Delta. /ID# 279329
Roeselare, West-Vlaanderen, Belgium
Recruiting
Beijing Hospital No. 2 /ID# 279666
Beijing, Beijing Municipality, China
Recruiting
Beijing Friendship Hospital /ID# 279766
Beijing, Beijing Municipality, China
Recruiting
Sun Yat-Sen University Cancer Center /ID# 279670
Guangzhou, Guangdong, China
Recruiting
Zhujiang Hospital /ID# 279667
Guangzhou, Guangdong, China
Recruiting
Guangxi Medical University Cancer Hospital /ID# 279707
Nanning, Guangxi, China
Recruiting
Union Hospital - Tongji Medical College /ID# 283649
Wuhan, Hubei, China
Recruiting
Hubei Cancer Hospital /ID# 279687
Wuhan, Hubei, China
Recruiting
China-Japan Union Hospital /ID# 279801
Changchun, Jilin, China
Recruiting
The Fourth Affiliated Hospital of China Medical University /ID# 279799
Shenyang, Liaoning, China
Recruiting
General Hospital Of Ningxia Medical University /ID# 279644
Yinchuan, Ningxia, China
Recruiting
Jinan Central Hospital /ID# 279705
Jinan, Shandong, China
Recruiting
First Affiliated Hospital of Shanxi Medical University /ID# 279665
Taiyuan, Shanxi, China
Recruiting
Sichuan Provincial People's Hospital /ID# 279685
Chengdu, Sichuan, China
Recruiting
People's Hospital of Xinjiang Uygur Autonomous Region /ID# 279876
Ürümqi, Xinjiang, China
Recruiting
Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874
Hangzhou, Zhejiang, China
Recruiting
Klinikum Am Steinenberg /ID# 279310
Reutlingen, Baden-Wurttemberg, Germany
Recruiting
Klinikum der Universitaet Muenchen Grosshadern /ID# 279304
Munich, Bavaria, Germany
Recruiting
Gemeinschaftspraxis Haematologie - Onkologie /ID# 279309
Dresden, Saxony, Germany
Recruiting
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 279302
Berlin, Germany
Recruiting
Asklepios Klinik Altona /ID# 279301
Hamburg, Germany
Recruiting
Athens Medical Center - Psychikon Branch /ID# 279134
Athens, Attica, Greece
Recruiting
General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 279133
Nea Kifissia, Attica, Greece
Recruiting
Theagenio Cancer Hospital /ID# 279129
Thessaloniki, Greece
Recruiting
Interbalkan Medical Center Of Thessaloniki /ID# 279288
Thessaloniki, Greece
Recruiting
National Cancer Center Hospital East /ID# 279917
Kashiwa-shi, Chiba, Japan
Recruiting
National Hospital Organization Shikoku Cancer Center /ID# 280224
Matsuyama, Ehime, Japan
Recruiting
Kobe City Medical Center General Hospital /ID# 280233
Kobe, Hyōgo, Japan
Recruiting
St Marianna University School Of Medicine /ID# 279902
Kawasaki-shi, Kanagawa, Japan
Recruiting
Osaka International Cancer Institute /ID# 281810
Osaka, Osaka, Japan
Recruiting
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 282329
Koto-ku, Tokyo, Japan
Recruiting
Unidade Local de Saude do Alto Ave, EPE /ID# 279703
Guimarães, Braga District, Portugal
Recruiting
Unidade Local de Saude de Loures-Odivelas /ID# 279636
Loures, Lisbon District, Portugal
Recruiting
Showing 60 of 83 sites — filter to narrow it down. 83 of the 83 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07525206. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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