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
AndroMETa-CRC
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
2 other identifiers
interventional
700
8 countries
35
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 colorectal-cancer
Started May 2026
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Start
First participant enrolled
May 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
July 29, 2026
July 1, 2026
2.9 years
April 7, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR)
Confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Up to Approximately 15 Months
Phase 3: Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
Up to Approximately 36 Months
Secondary Outcomes (5)
Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)
Up to Approximately 24 Months
Phase 3: Duration Of Response (DoR) as assessed by BICR
Up to Approximately 24 Months
Phase 3: Disease Control (DC) as assessed by BICR:
Up to Approximately 24 Months
Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domain at Week 13
Up to Approximately 13 Weeks
Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains
Up to Approximately 13 Weeks
Study Arms (2)
Ph 3: Telisotuzumab Adizutecan + Bevacizumab
EXPERIMENTALParticipants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.
Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab
EXPERIMENTALParticipants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration.
Interventions
Intravenous (IV)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (35)
Astera Cancer Care /ID# 279532
East Brunswick, New Jersey, 08816-4096, United States
Northwell Health Center for Advanced Medicine. /ID# 279590
Lake Success, New York, 11042, United States
Compass Oncology - Rose Quarter /ID# 280127
Portland, Oregon, 97227, United States
University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451
Seattle, Washington, 98109, United States
Imelda Ziekenhuis /ID# 279333
Bonheiden, Antwerpen, 2820, Belgium
Algemeen Ziekenhuis klina /ID# 279331
Brasschaat, Antwerpen, 2930, Belgium
Universitair Ziekenhuis Antwerpen /ID# 279334
Edegem, Antwerpen, 2650, Belgium
Institut Jules Bordet /ID# 279406
Anderlecht, Brussels Capital, 1070, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 279336
Charleroi, Hainaut, 6280, Belgium
AZ Maria Middelares /ID# 280141
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ-Delta. /ID# 279329
Roeselare, West-Vlaanderen, 8800, Belgium
Athens Medical Center - Psychikon Branch /ID# 279134
Athens, Attica, 11525, Greece
National Cancer Center Hospital East /ID# 279917
Kashiwa-shi, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center /ID# 280224
Matsuyama, Ehime, 791-0280, Japan
Kobe City Medical Center General Hospital /ID# 280233
Kobe, Hyōgo, 650-0047, Japan
Unidade Local de Saude do Alto Ave, EPE /ID# 279703
Guimarães, Braga District, 4835-044, Portugal
Unidade Local de Saude de Loures-Odivelas /ID# 279636
Loures, Lisbon District, 2674-514, Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637
Almada, Setúbal District, 2805-267, Portugal
Unidade Local de Saude de Santa Maria /ID# 279624
Lisbon, 1649-035, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702
Porto, 4200-072, Portugal
Dong-A University Medical Center /ID# 279610
Busan, Busan Gwang Yeogsi, 49201, South Korea
Gachon University Gil Medical Center /ID# 279592
Incheon, Gyeonggido, 21565, South Korea
CHA Bundang Medical Center /ID# 279589
Seongnam, Gyeonggido, 13496, South Korea
The Catholic University Of Korea St. Vincent's Hospital /ID# 279675
Suwon, Gyeonggido, 16247, South Korea
Hospital de la Santa Creu i Sant Pau /ID# 279642
Barcelona, 08041, Spain
Hospital General Universitario Gregorio Maranon /ID# 279650
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre /ID# 279659
Madrid, 28041, Spain
Hospital Universitario La Paz /ID# 279664
Madrid, 28046, Spain
Hospital Clinico Universitario de Valencia /ID# 279645
Valencia, 46010, Spain
Taipei Medical University Hospital /ID# 280607
Taipei, Tainan, 110, Taiwan
E-Da Cancer Hospital /ID# 279745
Kaohsiung City, 824, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708
New Taipei City, 235, Taiwan
Chi Mei Medical Center /ID# 279710
Tainan, 71004, Taiwan
Tri-Service General Hospital - Neihu Branch /ID# 279768
Taipei, 114, Taiwan
Taipei Municipal Wan Fang Hospital /ID# 280285
Taipei, 116, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2026
First Posted
April 13, 2026
Study Start
May 22, 2026
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
March 1, 2030
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.