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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

NCT07525206 · AbbVie
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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
About this study
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.
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.
Study design
Enrollment target: 990 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-22
Estimated completion: 2030-03
Last updated: 2026-09-22
Interventions
Drug: Telisotuzumab adizutecanDrug: BevacizumabDrug: Trifluridine/Tipiracil
Primary outcomes
  • Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) (Up to Approximately 15 Months)
  • Phase 3: Overall Survival (OS) (Up to Approximately 36 Months)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (77)
City Of Hope - Phoenix /ID# 279450Recruiting
Goodyear, Arizona, United States
Highlands Oncology Group - Springdale /ID# 279444Recruiting
Springdale, Arkansas, United States
City of Hope National Medical Center /ID# 279449Recruiting
Duarte, California, United States
Rocky Mountain Cancer Centers - Aurora /ID# 280112Recruiting
Aurora, Colorado, United States
Yale University School of Medicine /ID# 279373Recruiting
New Haven, Connecticut, United States
Moffitt Cancer Center /ID# 279325Recruiting
Tampa, Florida, United States
City Of Hope - Atlanta /ID# 280017Recruiting
Newnan, Georgia, United States
University of Chicago Medical Center /ID# 279365Recruiting
Chicago, Illinois, United States
Saint Lukes Hospital of Kansas City /ID# 279513Recruiting
Kansas City, Missouri, United States
Astera Cancer Care /ID# 279532Recruiting
East Brunswick, New Jersey, United States
Northwell Health Center for Advanced Medicine. /ID# 279590Recruiting
Lake Success, New York, United States
Duke University Medical Center /ID# 279322Recruiting
Durham, North Carolina, United States
Oncology Hematology Care - Blue Ash /ID# 280143Recruiting
Cincinnati, Ohio, United States
Compass Oncology - Rose Quarter /ID# 280127Recruiting
Portland, Oregon, United States
Texas Oncology - Abilene - Antilley Road /ID# 280120Recruiting
Abilene, Texas, United States
Blue Ridge Cancer Care - Blacksburg /ID# 280115Recruiting
Blacksburg, Virginia, United States
University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451Recruiting
Seattle, Washington, United States
Imelda Ziekenhuis /ID# 279333Recruiting
Bonheiden, Antwerpen, Belgium
Universitair Ziekenhuis Antwerpen /ID# 279334Recruiting
Edegem, Antwerpen, Belgium
Institut Jules Bordet /ID# 279406Recruiting
Anderlecht, Brussels Capital, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 279335Recruiting
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel /ID# 279535Recruiting
Jette, Brussels Capital, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 279336Recruiting
Charleroi, Hainaut, Belgium
Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 280014Recruiting
Yvoir, Namur, Belgium
AZ Maria Middelares /ID# 280141Recruiting
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 279330Recruiting
Leuven, Vlaams-Brabant, Belgium
AZ-Delta. /ID# 279329Recruiting
Roeselare, West-Vlaanderen, Belgium
Beijing Hospital No. 2 /ID# 279666Recruiting
Beijing, Beijing Municipality, China
Beijing Friendship Hospital /ID# 279766Recruiting
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Center /ID# 279670Recruiting
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital /ID# 279707Recruiting
Nanning, Guangxi, China
Union Hospital - Tongji Medical College /ID# 283649Recruiting
Wuhan, Hubei, China
China-Japan Union Hospital /ID# 279801Recruiting
Changchun, Jilin, China
The Fourth Affiliated Hospital of China Medical University /ID# 279799Recruiting
Shenyang, Liaoning, China
General Hospital Of Ningxia Medical University /ID# 279644Recruiting
Yinchuan, Ningxia, China
Jinan Central Hospital /ID# 279705Recruiting
Jinan, Shandong, China
First Affiliated Hospital of Shanxi Medical University /ID# 279665Recruiting
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital /ID# 279685Recruiting
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874Recruiting
Hangzhou, Zhejiang, China
Klinikum der Universitaet Muenchen Grosshadern /ID# 279304Recruiting
Munich, Bavaria, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 279302Recruiting
Berlin, Germany
Asklepios Klinik Altona /ID# 279301Recruiting
Hamburg, Germany
Athens Medical Center - Psychikon Branch /ID# 279134Recruiting
Athens, Attica, Greece
General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 279133Recruiting
Nea Kifissia, Attica, Greece
Theagenio Cancer Hospital /ID# 279129Recruiting
Thessaloniki, Greece
Interbalkan Medical Center Of Thessaloniki /ID# 279288Recruiting
Thessaloniki, Greece
National Cancer Center Hospital East /ID# 279917Recruiting
Kashiwa-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center /ID# 280224Recruiting
Matsuyama, Ehime, Japan
Kobe City Medical Center General Hospital /ID# 280233Recruiting
Kobe, Hyōgo, Japan
St Marianna University School Of Medicine /ID# 279902Recruiting
Kawasaki-shi, Kanagawa, Japan
Osaka International Cancer Institute /ID# 281810Recruiting
Osaka, Osaka, Japan
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 282329Recruiting
Koto-ku, Tokyo, Japan
Unidade Local de Saude do Alto Ave, EPE /ID# 279703Recruiting
Guimarães, Braga District, Portugal
Unidade Local de Saude de Loures-Odivelas /ID# 279636Recruiting
Loures, Lisbon District, Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637Recruiting
Almada, Setúbal District, Portugal
Unidade Local de Saude de Santa Maria /ID# 279624Recruiting
Lisbon, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702Recruiting
Porto, Portugal
Dong-A University Medical Center /ID# 279610Recruiting
Busan, Busan Gwang Yeogsi, South Korea
Gachon University Gil Medical Center /ID# 279592Recruiting
Incheon, Gyeonggido, South Korea
CHA Bundang Medical Center /ID# 279589Recruiting
Seongnam, Gyeonggido, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 279675Recruiting
Suwon, Gyeonggido, South Korea
Chonnam National University Hwasun Hospital /ID# 279787Recruiting
Hwasun-gun, Jeonranamdo, South Korea
Seoul National University Hospital /ID# 282730Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 282732Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Universitario Vall de Hebron /ID# 279651Recruiting
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau /ID# 279642Recruiting
Barcelona, Spain
Hospital General Universitario Gregorio Maranon /ID# 279650Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre /ID# 279659Recruiting
Madrid, Spain
Hospital Universitario La Paz /ID# 279664Recruiting
Madrid, Spain
Hospital Clinico Universitario de Valencia /ID# 279645Recruiting
Valencia, Spain
Hospital Universitario Miguel Servet /ID# 279653Recruiting
Zaragoza, Spain
Taipei Medical University Hospital /ID# 280607Recruiting
Taipei, Tainan, Taiwan
E-Da Cancer Hospital /ID# 279745Recruiting
Kaohsiung City, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708Recruiting
New Taipei City, Taiwan
Chi Mei Medical Center /ID# 279710Recruiting
Tainan, Taiwan
Tri-Service General Hospital - Neihu Branch /ID# 279768Recruiting
Taipei, Taiwan
Taipei Municipal Wan Fang Hospital /ID# 280285Recruiting
Taipei, Taiwan
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 · TrialPath