Clinical Research Directory
Browse clinical research sites, groups, and studies.
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 c-Met over-expressed 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 700 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
700
Start Date
2026-05-22
Completion Date
2030-03
Last Updated
2026-07-29
Healthy Volunteers
No
Conditions
Interventions
Telisotuzumab adizutecan
Intravenous (IV)
Bevacizumab
Intravenous (IV)
Trifluridine/Tipiracil
Oral
Locations (35)
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
Compass Oncology - Rose Quarter /ID# 280127
Portland, Oregon, United States
University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451
Seattle, Washington, United States
Imelda Ziekenhuis /ID# 279333
Bonheiden, Antwerpen, Belgium
Algemeen Ziekenhuis klina /ID# 279331
Brasschaat, Antwerpen, Belgium
Universitair Ziekenhuis Antwerpen /ID# 279334
Edegem, Antwerpen, Belgium
Institut Jules Bordet /ID# 279406
Anderlecht, Brussels Capital, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 279336
Charleroi, Hainaut, Belgium
AZ Maria Middelares /ID# 280141
Ghent, Oost-Vlaanderen, Belgium
AZ-Delta. /ID# 279329
Roeselare, West-Vlaanderen, Belgium
Athens Medical Center - Psychikon Branch /ID# 279134
Athens, Attica, 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
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
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
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