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
Recruiting · NCT07525206 · Interventional (participants receive a specific treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 other unapproved investigational agent.
- History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine/tipiracil.
- 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.
Where it is running
35 locations listed across 4 US 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
- Compass Oncology - Rose Quarter /ID# 280127 - Portland, Oregon, United States
- University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451 - Seattle, Washington, United States
- Hospital de la Santa Creu i Sant Pau /ID# 279642 - Barcelona, Spain
- E-Da Cancer Hospital /ID# 279745 - Kaohsiung City, Taiwan
- Unidade Local de Saude de Santa Maria /ID# 279624 - Lisbon, Portugal
- 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
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708 - New Taipei City, Taiwan
- Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702 - Porto, Portugal
- 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
- Hospital Clinico Universitario de Valencia /ID# 279645 - Valencia, Spain
- Imelda Ziekenhuis /ID# 279333 - Bonheiden, Antwerpen, Belgium
- Algemeen Ziekenhuis klina /ID# 279331 - Brasschaat, Antwerpen, Belgium
- Universitair Ziekenhuis Antwerpen /ID# 279334 - Edegem, Antwerpen, Belgium
- Athens Medical Center - Psychikon Branch /ID# 279134 - Athens, Attica, Greece
- Unidade Local de Saude do Alto Ave, EPE /ID# 279703 - Guimarães, Braga District, Portugal
- Institut Jules Bordet /ID# 279406 - Anderlecht, Brussels Capital, Belgium
- Dong-A University Medical Center /ID# 279610 - Busan, Busan Gwang Yeogsi, South Korea
- National Cancer Center Hospital East /ID# 279917 - Kashiwa-shi, Chiba, Japan
- National Hospital Organization Shikoku Cancer Center /ID# 280224 - Matsuyama, Ehime, Japan
- 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
- Grand Hopital de Charleroi - Les Viviers /ID# 279336 - Charleroi, Hainaut, Belgium
- Kobe City Medical Center General Hospital /ID# 280233 - Kobe, Hyōgo, Japan
- Unidade Local de Saude de Loures-Odivelas /ID# 279636 - Loures, Lisbon District, Portugal
- AZ Maria Middelares /ID# 280141 - Ghent, Oost-Vlaanderen, Belgium
- Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637 - Almada, Setúbal District, Portugal
- Taipei Medical University Hospital /ID# 280607 - Taipei, Tainan, Taiwan
- AZ-Delta. /ID# 279329 - Roeselare, West-Vlaanderen, Belgium