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Colorectal CancerPhase 3AndroMETa-CRCNCT07525206

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

A Phase 3 study testing Telisotuzumab adizutecan, Bevacizumab and Trifluridine/Tipiracil in people with Colorectal Cancer, run by AbbVie at 88 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Telisotuzumab adizutecan, Bevacizumab and Trifluridine/Tipiracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
990 participants
Where
88 sitesin 10 countries
Study dates
22 May 2026to Mar 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

88 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

88 sites in 10 countries

United States18 sites, 18 recruiting

  • Texas Oncology - Abilene - Antilley Road /ID# 280120

    Abilene, Texas, 79606

    Recruiting

  • Rocky Mountain Cancer Centers - Aurora /ID# 280112

    Aurora, Colorado, 80012

    Recruiting

  • Blue Ridge Cancer Care - Blacksburg /ID# 280115

    Blacksburg, Virginia, 24060

    Recruiting

  • University of Chicago Medical Center /ID# 279365

    Chicago, Illinois, 60637

    Recruiting

  • Oncology Hematology Care - Blue Ash /ID# 280143

    Cincinnati, Ohio, 45252

    Recruiting

  • City of Hope National Medical Center /ID# 279449

    Duarte, California, 91010

    Recruiting

  • Duke University Medical Center /ID# 279322

    Durham, North Carolina, 27710

    Recruiting

  • Astera Cancer Care /ID# 279532

    East Brunswick, New Jersey, 08816-4096

    Recruiting

  • City Of Hope - Phoenix /ID# 279450

    Goodyear, Arizona, 85338

    Recruiting

  • The University of Texas MD Anderson Cancer Center /ID# 279865

    Houston, Texas, 77030

    Recruiting

  • Saint Lukes Hospital of Kansas City /ID# 279513

    Kansas City, Missouri, 64111

    Recruiting

  • Northwell Health Center for Advanced Medicine. /ID# 279590

    Lake Success, New York, 11042

    Recruiting

  • Yale University School of Medicine /ID# 279373

    New Haven, Connecticut, 06510

    Recruiting

  • City Of Hope - Atlanta /ID# 280017

    Newnan, Georgia, 30265

    Recruiting

  • Compass Oncology - Rose Quarter /ID# 280127

    Portland, Oregon, 97227

    Recruiting

  • University Of Washington /ID# 281451

    Seattle, Washington, 98109

    Recruiting

  • Highlands Oncology Group - Springdale /ID# 279444

    Springdale, Arkansas, 72762

    Recruiting

  • Moffitt Cancer Center /ID# 279325

    Tampa, Florida, 33612

    Recruiting

Other trials in United States

China18 sites, 18 recruiting

  • Beijing Hospital No. 2 /ID# 279666

    Beijing, Beijing Municipality, 100006

    Recruiting

  • Beijing Friendship Hospital /ID# 279766

    Beijing, Beijing Municipality, 100050

    Recruiting

  • China-Japan Union Hospital /ID# 279801

    Changchun, Jilin, 130033

    Recruiting

  • Sichuan Provincial People's Hospital /ID# 279685

    Chengdu, Sichuan, 610072

    Recruiting

  • Sun Yat-Sen University Cancer Center /ID# 279670

    Guangzhou, Guangdong, 510060

    Recruiting

  • Zhujiang Hospital /ID# 279667

    Guangzhou, Guangdong, 510280

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874

    Hangzhou, Zhejiang, 310016

    Recruiting

  • Harbin Medical University Cancer Hospital /ID# 279961

    Harbin, Heilongjiang, 150081

    Recruiting

  • Jinan Central Hospital /ID# 279705

    Jinan, Shandong, 250013

    Recruiting

  • Guangxi Medical University Cancer Hospital /ID# 279707

    Nanning, Guangxi, 530021

    Recruiting

  • The Fourth Affiliated Hospital of China Medical University /ID# 279799

    Shenyang, Liaoning, 110001

    Recruiting

  • First Affiliated Hospital of Shanxi Medical University /ID# 279665

    Taiyuan, Shanxi, 030001

    Recruiting

  • People's Hospital of Xinjiang Uygur Autonomous Region /ID# 279876

    Ürümqi, Xinjiang, 830001

    Recruiting

  • Union Hospital - Tongji Medical College /ID# 283649

    Wuhan, Hubei, 430022

    Recruiting

  • Hubei Cancer Hospital /ID# 279687

    Wuhan, Hubei, 430079

    Recruiting

  • Affiliated Hospital Of Jiangnan University(Wuxi Fourth People'S Hospital ) /ID# 280200

    Wuxi, Jiangsu, 214122

    Recruiting

  • General Hospital Of Ningxia Medical University /ID# 279644

    Yinchuan, Ningxia, 750004

    Recruiting

  • Henan Cancer Hospital /ID# 279678

    Zhengzhou, Henan, 450008

    Recruiting

Other trials in China

Belgium10 sites, 10 recruiting

  • Institut Jules Bordet /ID# 279406

    Anderlecht, Brussels Capital, 1070

    Recruiting

  • Imelda Ziekenhuis /ID# 279333

    Bonheiden, Antwerpen, 2820

    Recruiting

  • Cliniques Universitaires UCL Saint-Luc /ID# 279335

    Brussels, Brussels Capital, 1200

    Recruiting

  • Grand Hopital de Charleroi - Les Viviers /ID# 279336

    Charleroi, Hainaut, 6280

    Recruiting

  • Universitair Ziekenhuis Antwerpen /ID# 279334

    Edegem, Antwerpen, 2650

    Recruiting

  • AZ Maria Middelares /ID# 280141

    Ghent, Oost-Vlaanderen, 9000

    Recruiting

  • Universitair Ziekenhuis Brussel /ID# 279535

    Jette, Brussels Capital, 1090

    Recruiting

  • Universitair Ziekenhuis Leuven /ID# 279330

    Leuven, Vlaams-Brabant, 3000

    Recruiting

  • AZ-Delta. /ID# 279329

    Roeselare, West-Vlaanderen, 8800

    Recruiting

  • Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 280014

    Yvoir, Namur, 5530

    Recruiting

Other trials in Belgium

Spain8 sites, 8 recruiting

  • Hospital Universitario Vall de Hebron /ID# 279651

    Barcelona, 08035

    Recruiting

  • Hospital de la Santa Creu i Sant Pau /ID# 279642

    Barcelona, 08041

    Recruiting

  • Hospital Universitario Reina Sofia /ID# 279682

    Córdoba, 14004

    Recruiting

  • Hospital General Universitario Gregorio Maranon /ID# 279650

    Madrid, 28007

    Recruiting

  • Hospital Universitario 12 de Octubre /ID# 279659

    Madrid, 28041

    Recruiting

  • Hospital Universitario La Paz /ID# 279664

    Madrid, 28046

    Recruiting

  • Hospital Clinico Universitario de Valencia /ID# 279645

    Valencia, 46010

    Recruiting

  • Hospital Universitario Miguel Servet /ID# 279653

    Zaragoza, 50009

    Recruiting

Other trials in Spain

South Korea7 sites, 7 recruiting

  • Dong-A University Medical Center /ID# 279610

    Busan, Busan Gwang Yeogsi, 49201

    Recruiting

  • Chonnam National University Hwasun Hospital /ID# 279787

    Hwasun-gun, Jeonranamdo, 58128

    Recruiting

  • Gachon University Gil Medical Center /ID# 279592

    Incheon, Gyeonggido, 21565

    Recruiting

  • CHA Bundang Medical Center /ID# 279589

    Seongnam, Gyeonggido, 13496

    Recruiting

  • Seoul National University Hospital /ID# 282730

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Asan Medical Center /ID# 282732

    Seoul, Seoul Teugbyeolsi, 05505

    Recruiting

  • The Catholic University Of Korea St. Vincent's Hospital /ID# 279675

    Suwon, Gyeonggido, 16247

    Recruiting

Other trials in South Korea

Japan6 sites, 6 recruiting

  • National Cancer Center Hospital East /ID# 279917

    Kashiwa-shi, Chiba, 277-8577

    Recruiting

  • St Marianna University School Of Medicine /ID# 279902

    Kawasaki-shi, Kanagawa, 216-8511

    Recruiting

  • Kobe City Medical Center General Hospital /ID# 280233

    Kobe, Hyōgo, 650-0047

    Recruiting

  • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 282329

    Koto-ku, Tokyo, 135-8550

    Recruiting

  • National Hospital Organization Shikoku Cancer Center /ID# 280224

    Matsuyama, Ehime, 791-0280

    Recruiting

  • Osaka International Cancer Institute /ID# 281810

    Osaka, Osaka, 5418567

    Recruiting

Other trials in Japan

Taiwan6 sites, 6 recruiting

  • E-Da Cancer Hospital /ID# 279745

    Kaohsiung City, 824

    Recruiting

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708

    New Taipei City, 235

    Recruiting

  • Chi Mei Medical Center /ID# 279710

    Tainan, 71004

    Recruiting

  • Taipei Medical University Hospital /ID# 280607

    Taipei, Tainan, 110

    Recruiting

  • Tri-Service General Hospital - Neihu Branch /ID# 279768

    Taipei, 114

    Recruiting

  • Taipei Municipal Wan Fang Hospital /ID# 280285

    Taipei, 116

    Recruiting

Other trials in Taiwan

Germany5 sites, 5 recruiting

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 279302

    Berlin, 13353

    Recruiting

  • Gemeinschaftspraxis Haematologie - Onkologie /ID# 279309

    Dresden, Saxony, 01307

    Recruiting

  • Asklepios Klinik Altona /ID# 279301

    Hamburg, 22763

    Recruiting

  • Klinikum der Universitaet Muenchen Grosshadern /ID# 279304

    Munich, Bavaria, 81337

    Recruiting

  • Klinikum Am Steinenberg /ID# 279310

    Reutlingen, Baden-Wurttemberg, 72764

    Recruiting

Other trials in Germany

Greece5 sites, 5 recruiting

  • Athens Medical Center - Psychikon Branch /ID# 279134

    Athens, Attica, 11525

    Recruiting

  • University General Hospital Attikon /ID# 279123

    Chaïdári, Attica, 12462

    Recruiting

  • General Oncology Hospital of Kifisia Agioi Anargyroi /ID# 279133

    Nea Kifissia, Attica, 14564

    Recruiting

  • Theagenio Cancer Hospital /ID# 279129

    Thessaloniki, 54639

    Recruiting

  • Interbalkan Medical Center Of Thessaloniki /ID# 279288

    Thessaloniki, 57001

    Recruiting

Other trials in Greece

Portugal5 sites, 5 recruiting

  • Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637

    Almada, Setúbal District, 2805-267

    Recruiting

  • Unidade Local de Saude do Alto Ave, EPE /ID# 279703

    Guimarães, Braga District, 4835-044

    Recruiting

  • Unidade Local de Saude de Santa Maria /ID# 279624

    Lisbon, 1649-035

    Recruiting

  • Unidade Local de Saude de Loures-Odivelas /ID# 279636

    Loures, Lisbon District, 2674-514

    Recruiting

  • Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702

    Porto, 4200-072

    Recruiting

Other trials in Portugal

About this study

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

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.

Read more

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.

Being tested
Telisotuzumab adizutecan, Bevacizumab, Trifluridine/Tipiracil
Keywords
Colorectal Cancer, Telisotuzumab Adizutecan, Bevacizumab, Trifluridine and Tipiracil, AndroMETa-CRC-560
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telisotuzumab adizutecanDrug

    Intravenous (IV)

  • BevacizumabDrug

    Intravenous (IV)

  • Trifluridine/TipiracilDrug

    Oral

Study groups in NCT07525206
Study groupRoleWhat they receive
Ph 3: Telisotuzumab Adizutecan + BevacizumabExperimentalParticipants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.
Receives: Drug: Telisotuzumab adizutecan; Drug: Bevacizumab
Ph 3: SOC Trifluridine and Tipiracil + BevacizumabExperimentalParticipants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration.
Receives: Drug: Bevacizumab; Drug: Trifluridine/Tipiracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Approximately 15 Months

  2. Phase 3: Overall Survival (OS)

    OS is defined as the time from date of randomization to the event of death from any cause.

    Measured: Up to Approximately 36 Months

Secondary outcomes (5)

  1. Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup >= 10%, 3+

    OS is defined as the time from date of randomization to the event of death from any cause.

    Measured: Up to Approximately 36 Months

  2. Phase 3: Overall Survival (OS) in Participants With c-Met Subgroup < 10%, 3+

    OS is defined as the time from date of randomization to the event of death from any cause.

    Measured: Up to Approximately 36 Months

  3. Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR)

    PFS is defined as the time from date of randomization to the first occurrence of radiographic progression based on RECIST v1.1 or death from any cause, whichever occurs earlier.

    Measured: Up to Approximately 24 Months

  4. Phase 3: Duration Of Response (DoR) as assessed by BICR

    DoR defined as time from the date of initial response of confirmed CR or PR to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause, whichever occurs first. DoR is defined for subjects with confirmed CR/PR.

    Measured: Up to Approximately 24 Months

  5. Phase 3: Disease Control (DC) as assessed by BICR:

    DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, v1.1

    Measured: Up to Approximately 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start22 May 2026
  3. Primary completionMay 2029 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
990 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07525206
Sponsor's protocol ID
M24-560
Other IDs
2025-521712-19-00, 2025
Acronym
AndroMETa-CRC
Status last verified
Oct 2026
First submitted
7 Apr 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Cecchini M, Cruz-Correa M, Han SW, Raghav K, Landa-Magdalena A, Strickler JH, Calvo A, Hollebecque A, Nakajima TE, Perl G, Jain V, Hunter Z, Chan EM, Blaney M, Li R, Vasilopoulos A, Parikh A, Sharma MR. A randomized Phase 1 study of telisotuzumab adizutecan (ABBV-400, Temab-A) in combination with bevacizumab versus trifluridine-tipiracil with bevacizumab in patients with metastatic colorectal cancer. Ann Oncol. 2026 Oct 24:S0923-7534(26)06887-0. doi: 10.1016/j.annonc.2026.10.105. Online ahead of print.

    PubMed 42926107

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telisotuzumab adizutecan, Bevacizumab and Trifluridine/Tipiracil in people with Colorectal Cancer, run by AbbVie at 88 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, China, Belgium, Spain, South Korea and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) (time frame: Up to Approximately 15 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07525206, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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