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RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07525206

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Telisotuzumab adizutecan (Drug)
    Intravenous (IV)
  • Bevacizumab (Drug)
    Intravenous (IV)
  • Trifluridine/Tipiracil (Drug)
    Oral

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.

Conditions

Colorectal Cancer

Locations

  • 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
  • The University of Texas MD Anderson Cancer Center /ID# 279865 — Houston, Texas, United States
  • Blue Ridge Cancer Care - Blacksburg /ID# 280115 — Blacksburg, Virginia, United States
  • University Of Washington /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 Hospital No. 2 /ID# 279666 — Beijing, Beijing Municipality, China
  • Beijing Friendship Hospital /ID# 279766 — Beijing, Beijing Municipality, China
  • Sun Yat-Sen University Cancer Center /ID# 279670 — Guangzhou, Guangdong, China
  • Zhujiang Hospital /ID# 279667 — Guangzhou, Guangdong, China
  • Guangxi Medical University Cancer Hospital /ID# 279707 — Nanning, Guangxi, China
  • Harbin Medical University Cancer Hospital /ID# 279961 — Harbin, Heilongjiang, China
  • Henan Cancer Hospital /ID# 279678 — Zhengzhou, Henan, China
  • Union Hospital - Tongji Medical College /ID# 283649 — Wuhan, Hubei, China
  • Hubei Cancer Hospital /ID# 279687 — Wuhan, Hubei, China
  • Affiliated Hospital Of Jiangnan University(Wuxi Fourth People'S Hospital ) /ID# 280200 — Wuxi, Jiangsu, 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
  • Jinan Central Hospital /ID# 279705 — Jinan, Shandong, China
  • First Affiliated Hospital of Shanxi Medical University /ID# 279665 — Taiyuan, Shanxi, China
  • Sichuan Provincial People's Hospital /ID# 279685 — Chengdu, Sichuan, China
  • People's Hospital of Xinjiang Uygur Autonomous Region /ID# 279876 — Ürümqi, Xinjiang, China
  • Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874 — Hangzhou, Zhejiang, China
  • Klinikum Am Steinenberg /ID# 279310 — Reutlingen, Baden-Wurttemberg, Germany
  • Klinikum der Universitaet Muenchen Grosshadern /ID# 279304 — Munich, Bavaria, Germany
  • Gemeinschaftspraxis Haematologie - Onkologie /ID# 279309 — Dresden, Saxony, Germany
  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 279302 — Berlin, Germany
  • Asklepios Klinik Altona /ID# 279301 — Hamburg, Germany
  • Athens Medical Center - Psychikon Branch /ID# 279134 — Athens, Attica, Greece
  • University General Hospital Attikon /ID# 279123 — Chaïdári, 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 Universitario Reina Sofia /ID# 279682 — Córdoba, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record