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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telisotuzumab adizutecan, Bevacizumab, Trifluridine/Tipiracil.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Greece, Japan, Portugal +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Telisotuzumab adizutecan
Intravenous (IV) - Drug Bevacizumab
Intravenous (IV) - Drug Trifluridine/Tipiracil
Oral
Primary outcome measures
- Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) [Time frame: Up to Approximately 15 Months]
- Phase 3: Overall Survival (OS) [Time frame: Up to Approximately 36 Months]
Secondary outcome measures (5)
- Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) [Time frame: Up to Approximately 24 Months]
- Phase 3: Duration Of Response (DoR) as assessed by BICR [Time frame: Up to Approximately 24 Months]
- Phase 3: Disease Control (DC) as assessed by BICR: [Time frame: Up to Approximately 24 Months]
- Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domain at Week 13 [Time frame: Up to Approximately 13 Weeks]
- Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains [Time frame: Up to Approximately 13 Weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 7 centers
- Imelda Ziekenhuis /ID# 279333 — Bonheiden
- Algemeen Ziekenhuis klina /ID# 279331 — Brasschaat
- Universitair Ziekenhuis Antwerpen /ID# 279334 — Edegem
- Institut Jules Bordet /ID# 279406 — Anderlecht
- Grand Hopital de Charleroi - Les Viviers /ID# 279336 — Charleroi
- AZ Maria Middelares /ID# 280141 — Ghent
- AZ-Delta. /ID# 279329 — Roeselare
Taiwan · 6 centers
- Taipei Medical University Hospital /ID# 280607 — Taipei
- E-Da Cancer Hospital /ID# 279745 — Kaohsiung City
- Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708 — New Taipei City
- Chi Mei Medical Center /ID# 279710 — Tainan
- Tri-Service General Hospital - Neihu Branch /ID# 279768 — Taipei
- Taipei Municipal Wan Fang Hospital /ID# 280285 — Taipei
Portugal · 5 centers
- Unidade Local de Saude do Alto Ave, EPE /ID# 279703 — Guimarães
- Unidade Local de Saude de Loures-Odivelas /ID# 279636 — Loures
- Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637 — Almada
- Unidade Local de Saude de Santa Maria /ID# 279624 — Lisbon
- Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702 — Porto
Spain · 5 centers
- Hospital de la Santa Creu i Sant Pau /ID# 279642 — Barcelona
- Hospital General Universitario Gregorio Maranon /ID# 279650 — Madrid
- Hospital Universitario 12 de Octubre /ID# 279659 — Madrid
- Hospital Universitario La Paz /ID# 279664 — Madrid
- Hospital Clinico Universitario de Valencia /ID# 279645 — Valencia
United States · 4 centers
- Astera Cancer Care /ID# 279532 — East Brunswick
- Northwell Health Center for Advanced Medicine. /ID# 279590 — Lake Success
- Compass Oncology - Rose Quarter /ID# 280127 — Portland
- University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451 — Seattle
South Korea · 4 centers
- Dong-A University Medical Center /ID# 279610 — Busan
- Gachon University Gil Medical Center /ID# 279592 — Incheon
- CHA Bundang Medical Center /ID# 279589 — Seongnam
- The Catholic University Of Korea St. Vincent's Hospital /ID# 279675 — Suwon
Japan · 3 centers
- National Cancer Center Hospital East /ID# 279917 — Kashiwa-shi
- National Hospital Organization Shikoku Cancer Center /ID# 280224 — Matsuyama
- Kobe City Medical Center General Hospital /ID# 280233 — Kobe
Greece · 1 center
- Athens Medical Center - Psychikon Branch /ID# 279134 — Athens
Identifiers
NCT: NCT07525206 · M24-560 · 2025-521712-19-00