NCT07525206RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 990 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 22 May 2026
- Primary completion date
- 31 May 2029
- Lead sponsor
- AbbVie
- Diseases
- Colorectal cancer
- NCT number
- NCT07525206
- EU CT number
- 2025-521712-19-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 990
- From 22 May 2026 to the primary completion date, 31 May 2029
- 94 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any Top-1 inhibitor ADC.
Other illness
- 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.
Lab values
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (94)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Imelda Coordinator of this site? Confirm its status | Bonheiden | Belgium | Recruiting |
| Grand Hopital de Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Az Maria Middelares Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Coordinator of this site? Confirm its status | Yvoir | Belgium | Recruiting |
| Beijing Friendship Hospital /ID# 279766 Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Hospital No. 2 /ID# 279666 Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| China-Japan Union Hospital /ID# 279801 Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Sichuan Provincial People's Hospital /ID# 279685 Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Sun Yat-Sen University Cancer Center /ID# 279670 Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhujiang Hospital /ID# 279667 Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874 Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Harbin Medical University Cancer Hospital /ID# 279961 Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| Jinan Central Hospital /ID# 279705 Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Guangxi Medical University Cancer Hospital /ID# 279707 Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| The Fourth Affiliated Hospital of China Medical University /ID# 279799 Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| First Affiliated Hospital of Shanxi Medical University /ID# 279665 Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| People's Hospital of Xinjiang Uygur Autonomous Region /ID# 279876 Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
| Hubei Cancer Hospital /ID# 279687 Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Union Hospital - Tongji Medical College /ID# 283649 Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Affiliated Hospital Of Jiangnan University(Wuxi Fourth People'S Hospital ) /ID# 280200 Coordinator of this site? Confirm its status | Wuxi | China | Recruiting |
| General Hospital Of Ningxia Medical University /ID# 279644 Coordinator of this site? Confirm its status | Yinchuan | China | Recruiting |
| Henan Cancer Hospital /ID# 279678 Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Gemeinschaftspraxis Haematologie Onkologie Coordinator of this site? Confirm its status | Dresden | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Asklepios Kliniken Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Kreiskliniken Reutlingen gGmbH Coordinator of this site? Confirm its status | Reutlingen | Germany | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Areteio Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Recruiting |
| General Oncological Hospital Of Kifissia Agioi Anargyroi Coordinator of this site? Confirm its status | Kifissia | Greece | Recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Theageneio Cancer Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| National Cancer Center Hospital East /ID# 279917 Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Recruiting |
| St Marianna University School Of Medicine /ID# 279902 Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Recruiting |
| Kobe City Medical Center General Hospital /ID# 280233 Coordinator of this site? Confirm its status | Kobe | Japan | Recruiting |
| The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 282329 Coordinator of this site? Confirm its status | Koto-ku | Japan | Recruiting |
| National Hospital Organization Shikoku Cancer Center /ID# 280224 Coordinator of this site? Confirm its status | Matsuyama | Japan | Recruiting |
| Osaka International Cancer Institute /ID# 281810 Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Dong-A University Medical Center /ID# 279610 Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Chonnam National University Hwasun Hospital /ID# 279787 Coordinator of this site? Confirm its status | Hwasun-gun | South Korea | Recruiting |
| Gachon University Gil Medical Center /ID# 279592 Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| CHA Bundang Medical Center /ID# 279589 Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| Asan Medical Center /ID# 282732 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital /ID# 282730 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University Of Korea St. Vincent's Hospital /ID# 279675 Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. Coordinator of this site? Confirm its status | Almada | Portugal | Recruiting |
| Unidade Local De Saude Do Alto Ave E.P.E. Coordinator of this site? Confirm its status | Guimaraes | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Loures-Odivelas EPE Coordinator of this site? Confirm its status | Loures | Portugal | Recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| E-Da Cancer Hospital /ID# 279745 Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708 Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Recruiting |
| Chi Mei Medical Center /ID# 279710 Coordinator of this site? Confirm its status | Tainan | Taiwan | Recruiting |
| Tri-Service General Hospital - Neihu Branch /ID# 279768 Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Municipal Wan Fang Hospital /ID# 280285 Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Medical University Hospital /ID# 280607 Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Texas Oncology - Abilene - Antilley Road /ID# 280120 Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| Rocky Mountain Cancer Centers - Aurora /ID# 280112 Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Blue Ridge Cancer Care - Blacksburg /ID# 280115 Coordinator of this site? Confirm its status | Blacksburg | United States | Recruiting |
| University of Chicago Medical Center /ID# 279365 Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Oncology Hematology Care - Blue Ash /ID# 280143 Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| City of Hope National Medical Center /ID# 279449 Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Duke University Medical Center /ID# 279322 Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Astera Cancer Care /ID# 279532 Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| City Of Hope - Phoenix /ID# 279450 Coordinator of this site? Confirm its status | Goodyear | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center /ID# 279865 Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Saint Lukes Hospital of Kansas City /ID# 279513 Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Northwell Health Center for Advanced Medicine. /ID# 279590 Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| Yale University School of Medicine /ID# 279373 Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| City Of Hope - Atlanta /ID# 280017 Coordinator of this site? Confirm its status | Newnan | United States | Recruiting |
| Compass Oncology - Rose Quarter /ID# 280127 Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| University Of Washington /ID# 281451 Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Highlands Oncology Group - Springdale /ID# 279444 Coordinator of this site? Confirm its status | Springdale | United States | Recruiting |
| Moffitt Cancer Center /ID# 279325 Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
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This page is information, not medical advice. Discuss any trial with your doctor.