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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 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.
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 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.
Study design
Enrollment target: 700 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-22
Estimated completion: 2030-03
Last updated: 2026-07-20
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 (21)
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
University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451Recruiting
Seattle, Washington, United States
Algemeen Ziekenhuis klina /ID# 279331Not Yet Recruiting
Brasschaat, Antwerpen, Belgium
National Cancer Center Hospital East /ID# 279917Recruiting
Kashiwa-shi, Chiba, 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
Hospital de la Santa Creu i Sant Pau /ID# 279642Recruiting
Barcelona, Spain
Hospital Universitario 12 de Octubre /ID# 279659Recruiting
Madrid, 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