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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
Sponsor: AbbVie
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
990
Start Date
2026-05-22
Completion Date
2030-03
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Telisotuzumab adizutecan
Intravenous (IV)
Bevacizumab
Intravenous (IV)
Trifluridine/Tipiracil
Oral
Locations (69)
City Of Hope - Phoenix /ID# 279450
Goodyear, Arizona, United States
Highlands Oncology Group - Springdale /ID# 279444
Springdale, Arkansas, United States
City of Hope National Medical Center /ID# 279449
Duarte, California, United States
Rocky Mountain Cancer Centers - Aurora /ID# 280112
Aurora, Colorado, United States
Yale University School of Medicine /ID# 279373
New Haven, Connecticut, United States
Moffitt Cancer Center /ID# 279325
Tampa, Florida, United States
City Of Hope - Atlanta /ID# 280017
Newnan, Georgia, United States
University of Chicago Medical Center /ID# 279365
Chicago, Illinois, United States
Saint Lukes Hospital of Kansas City /ID# 279513
Kansas City, Missouri, United States
Astera Cancer Care /ID# 279532
East Brunswick, New Jersey, United States
Northwell Health Center for Advanced Medicine. /ID# 279590
Lake Success, New York, United States
Duke University Medical Center /ID# 279322
Durham, North Carolina, United States
Oncology Hematology Care - Blue Ash /ID# 280143
Cincinnati, Ohio, United States
Compass Oncology - Rose Quarter /ID# 280127
Portland, Oregon, United States
Texas Oncology - Abilene - Antilley Road /ID# 280120
Abilene, Texas, United States
Blue Ridge Cancer Care - Blacksburg /ID# 280115
Blacksburg, Virginia, United States
University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451
Seattle, Washington, United States
Imelda Ziekenhuis /ID# 279333
Bonheiden, Antwerpen, Belgium
Universitair Ziekenhuis Antwerpen /ID# 279334
Edegem, Antwerpen, Belgium
Institut Jules Bordet /ID# 279406
Anderlecht, Brussels Capital, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 279335
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel /ID# 279535
Jette, Brussels Capital, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 279336
Charleroi, Hainaut, Belgium
Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 280014
Yvoir, Namur, Belgium
AZ Maria Middelares /ID# 280141
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 279330
Leuven, Vlaams-Brabant, Belgium
AZ-Delta. /ID# 279329
Roeselare, West-Vlaanderen, Belgium
Beijing Friendship Hospital /ID# 279766
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Center /ID# 279670
Guangzhou, Guangdong, China
China-Japan Union Hospital /ID# 279801
Changchun, Jilin, China
The Fourth Affiliated Hospital of China Medical University /ID# 279799
Shenyang, Liaoning, China
General Hospital Of Ningxia Medical University /ID# 279644
Yinchuan, Ningxia, China
First Affiliated Hospital of Shanxi Medical University /ID# 279665
Taiyuan, Shanxi, China
Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874
Hangzhou, Zhejiang, China
Athens Medical Center - Psychikon Branch /ID# 279134
Athens, Attica, Greece
General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 279133
Nea Kifissia, Attica, Greece
Theagenio Cancer Hospital /ID# 279129
Thessaloniki, Greece
Interbalkan Medical Center Of Thessaloniki /ID# 279288
Thessaloniki, Greece
National Cancer Center Hospital East /ID# 279917
Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center /ID# 280224
Matsuyama, Ehime, Japan
Kobe City Medical Center General Hospital /ID# 280233
Kobe, Hyōgo, Japan
St Marianna University School Of Medicine /ID# 279902
Kawasaki-shi, Kanagawa, Japan
Osaka International Cancer Institute /ID# 281810
Osaka, Osaka, Japan
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 282329
Koto-ku, Tokyo, Japan
Unidade Local de Saude do Alto Ave, EPE /ID# 279703
Guimarães, Braga District, Portugal
Unidade Local de Saude de Loures-Odivelas /ID# 279636
Loures, Lisbon District, Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637
Almada, Setúbal District, Portugal
Unidade Local de Saude de Santa Maria /ID# 279624
Lisbon, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702
Porto, Portugal
Dong-A University Medical Center /ID# 279610
Busan, Busan Gwang Yeogsi, South Korea
Gachon University Gil Medical Center /ID# 279592
Incheon, Gyeonggido, South Korea
CHA Bundang Medical Center /ID# 279589
Seongnam, Gyeonggido, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 279675
Suwon, Gyeonggido, South Korea
Chonnam National University Hwasun Hospital /ID# 279787
Hwasun-gun, Jeonranamdo, South Korea
Seoul National University Hospital /ID# 282730
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 282732
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario Vall de Hebron /ID# 279651
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau /ID# 279642
Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 279650
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 279659
Madrid, Spain
Hospital Universitario La Paz /ID# 279664
Madrid, Spain
Hospital Clinico Universitario de Valencia /ID# 279645
Valencia, Spain
Hospital Universitario Miguel Servet /ID# 279653
Zaragoza, Spain
Taipei Medical University Hospital /ID# 280607
Taipei, Tainan, Taiwan
E-Da Cancer Hospital /ID# 279745
Kaohsiung City, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708
New Taipei City, Taiwan
Chi Mei Medical Center /ID# 279710
Tainan, Taiwan
Tri-Service General Hospital - Neihu Branch /ID# 279768
Taipei, Taiwan
Taipei Municipal Wan Fang Hospital /ID# 280285
Taipei, Taiwan