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
3 other identifiers
interventional
990
10 countries
84
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started May 2026
84 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
October 2, 2026
September 1, 2026
2.9 years
April 7, 2026
September 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR)
Best overall response of 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 date of randomization to the event of death from any cause.
Up to Approximately 36 Months
Secondary Outcomes (5)
Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup >= 10%, 3+
Up to Approximately 36 Months
Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup < 10%, 3+
Up to Approximately 36 Months
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
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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (84)
City Of Hope - Phoenix /ID# 279450
Goodyear, Arizona, 85338, United States
Highlands Oncology Group - Springdale /ID# 279444
Springdale, Arkansas, 72762, United States
City of Hope National Medical Center /ID# 279449
Duarte, California, 91010, United States
Rocky Mountain Cancer Centers - Aurora /ID# 280112
Aurora, Colorado, 80012, United States
Yale University School of Medicine /ID# 279373
New Haven, Connecticut, 06510, United States
Moffitt Cancer Center /ID# 279325
Tampa, Florida, 33612, United States
City Of Hope - Atlanta /ID# 280017
Newnan, Georgia, 30265, United States
University of Chicago Medical Center /ID# 279365
Chicago, Illinois, 60637, United States
Saint Lukes Hospital of Kansas City /ID# 279513
Kansas City, Missouri, 64111, United States
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
Duke University Medical Center /ID# 279322
Durham, North Carolina, 27710, United States
Oncology Hematology Care - Blue Ash /ID# 280143
Cincinnati, Ohio, 45252, United States
Compass Oncology - Rose Quarter /ID# 280127
Portland, Oregon, 97227, United States
Texas Oncology - Abilene - Antilley Road /ID# 280120
Abilene, Texas, 79606, United States
The University of Texas MD Anderson Cancer Center /ID# 279865
Houston, Texas, 77030, United States
Blue Ridge Cancer Care - Blacksburg /ID# 280115
Blacksburg, Virginia, 24060, 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
Universitair Ziekenhuis Antwerpen /ID# 279334
Edegem, Antwerpen, 2650, Belgium
Institut Jules Bordet /ID# 279406
Anderlecht, Brussels Capital, 1070, Belgium
Cliniques Universitaires UCL Saint-Luc /ID# 279335
Brussels, Brussels Capital, 1200, Belgium
Universitair Ziekenhuis Brussel /ID# 279535
Jette, Brussels Capital, 1090, Belgium
Grand Hopital de Charleroi - Les Viviers /ID# 279336
Charleroi, Hainaut, 6280, Belgium
Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 280014
Yvoir, Namur, 5530, Belgium
AZ Maria Middelares /ID# 280141
Ghent, Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 279330
Leuven, Vlaams-Brabant, 3000, Belgium
AZ-Delta. /ID# 279329
Roeselare, West-Vlaanderen, 8800, Belgium
Beijing Hospital No. 2 /ID# 279666
Beijing, Beijing Municipality, 100006, China
Beijing Friendship Hospital /ID# 279766
Beijing, Beijing Municipality, 100050, China
Sun Yat-Sen University Cancer Center /ID# 279670
Guangzhou, Guangdong, 510060, China
Zhujiang Hospital /ID# 279667
Guangzhou, Guangdong, 510280, China
Guangxi Medical University Cancer Hospital /ID# 279707
Nanning, Guangxi, 530021, China
Union Hospital - Tongji Medical College /ID# 283649
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital /ID# 279687
Wuhan, Hubei, 430079, China
Affiliated Hospital Of Jiangnan University(Wuxi Fourth People'S Hospital ) /ID# 280200
Wuxi, Jiangsu, 214122, China
China-Japan Union Hospital /ID# 279801
Changchun, Jilin, 130033, China
The Fourth Affiliated Hospital of China Medical University /ID# 279799
Shenyang, Liaoning, 110001, China
General Hospital Of Ningxia Medical University /ID# 279644
Yinchuan, Ningxia, 750004, China
Jinan Central Hospital /ID# 279705
Jinan, Shandong, 250013, China
First Affiliated Hospital of Shanxi Medical University /ID# 279665
Taiyuan, Shanxi, 030001, China
Sichuan Provincial People's Hospital /ID# 279685
Chengdu, Sichuan, 610072, China
People's Hospital of Xinjiang Uygur Autonomous Region /ID# 279876
Ürümqi, Xinjiang, 830001, China
Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874
Hangzhou, Zhejiang, 310016, China
Klinikum Am Steinenberg /ID# 279310
Reutlingen, Baden-Wurttemberg, 72764, Germany
Klinikum der Universitaet Muenchen Grosshadern /ID# 279304
Munich, Bavaria, 81337, Germany
Gemeinschaftspraxis Haematologie - Onkologie /ID# 279309
Dresden, Saxony, 01307, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 279302
Berlin, 10117, Germany
Asklepios Klinik Altona /ID# 279301
Hamburg, 22763, Germany
Athens Medical Center - Psychikon Branch /ID# 279134
Athens, Attica, 11525, Greece
General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 279133
Nea Kifissia, Attica, 14564, Greece
Theagenio Cancer Hospital /ID# 279129
Thessaloniki, 54639, Greece
Interbalkan Medical Center Of Thessaloniki /ID# 279288
Thessaloniki, 57001, 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
St Marianna University School Of Medicine /ID# 279902
Kawasaki-shi, Kanagawa, 216-8511, Japan
Osaka International Cancer Institute /ID# 281810
Osaka, Osaka, 5418567, Japan
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 282329
Koto-ku, Tokyo, 135-8550, 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
Chonnam National University Hwasun Hospital /ID# 279787
Hwasun-gun, Jeonranamdo, 58128, South Korea
Seoul National University Hospital /ID# 282730
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center /ID# 282732
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Hospital Universitario Vall de Hebron /ID# 279651
Barcelona, 08035, Spain
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
Hospital Universitario Miguel Servet /ID# 279653
Zaragoza, 50009, 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
October 2, 2026
Record last verified: 2026-09
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.