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NCT07525206RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
990 (estimated)
First submitted
7 Apr 2026
Start date
22 May 2026
Primary completion date
31 May 2029
Lead sponsor
AbbVie
NCT number
NCT07525206
EU CT number
2025-521712-19-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 990
  • From 22 May 2026 to the primary completion date, 31 May 2029
  • 94 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any Top-1 inhibitor ADC.

Other illness

  • 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.

Lab values

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (94)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Jules Bordet
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AnderlechtBelgiumRecruiting
Imelda
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BonheidenBelgiumRecruiting
Grand Hopital de Charleroi
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CharleroiBelgiumRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
Az Maria Middelares Gent
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GentBelgiumRecruiting
UZ Brussel
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JetteBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumRecruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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YvoirBelgiumRecruiting
Beijing Friendship Hospital /ID# 279766
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BeijingChinaRecruiting
Beijing Hospital No. 2 /ID# 279666
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BeijingChinaRecruiting
China-Japan Union Hospital /ID# 279801
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ChangchunChinaRecruiting
Sichuan Provincial People's Hospital /ID# 279685
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ChengduChinaRecruiting
Sun Yat-Sen University Cancer Center /ID# 279670
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GuangzhouChinaRecruiting
Zhujiang Hospital /ID# 279667
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GuangzhouChinaRecruiting
Sir Run Run Shaw Hospital Zhejiang University School Of Medicine /ID# 279874
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HangzhouChinaRecruiting
Harbin Medical University Cancer Hospital /ID# 279961
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HarbinChinaRecruiting
Jinan Central Hospital /ID# 279705
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JinanChinaRecruiting
Guangxi Medical University Cancer Hospital /ID# 279707
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NanningChinaRecruiting
The Fourth Affiliated Hospital of China Medical University /ID# 279799
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ShenyangChinaRecruiting
First Affiliated Hospital of Shanxi Medical University /ID# 279665
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TaiyuanChinaRecruiting
People's Hospital of Xinjiang Uygur Autonomous Region /ID# 279876
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ÜrümqiChinaRecruiting
Hubei Cancer Hospital /ID# 279687
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WuhanChinaRecruiting
Union Hospital - Tongji Medical College /ID# 283649
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WuhanChinaRecruiting
Affiliated Hospital Of Jiangnan University(Wuxi Fourth People'S Hospital ) /ID# 280200
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WuxiChinaRecruiting
General Hospital Of Ningxia Medical University /ID# 279644
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YinchuanChinaRecruiting
Henan Cancer Hospital /ID# 279678
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ZhengzhouChinaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Gemeinschaftspraxis Haematologie Onkologie
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DresdenGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Asklepios Kliniken Hamburg GmbH
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HamburgGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
LMU Klinikum Muenchen AöR
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MunichGermanyRecruiting
Kreiskliniken Reutlingen gGmbH
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ReutlingenGermanyRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario Reina Sofia
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CórdobaSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainRecruiting
Athens Medical Center S.A.
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AthensGreeceRecruiting
Areteio Hospital
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AthensGreeceRecruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceRecruiting
General Oncological Hospital Of Kifissia Agioi Anargyroi
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KifissiaGreeceRecruiting
Athens Medical Center S.A.
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ThessalonikiGreeceRecruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceRecruiting
National Cancer Center Hospital East /ID# 279917
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Kashiwa-shiJapanRecruiting
St Marianna University School Of Medicine /ID# 279902
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Kawasaki-shiJapanRecruiting
Kobe City Medical Center General Hospital /ID# 280233
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KobeJapanRecruiting
The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 282329
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Koto-kuJapanRecruiting
National Hospital Organization Shikoku Cancer Center /ID# 280224
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MatsuyamaJapanRecruiting
Osaka International Cancer Institute /ID# 281810
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OsakaJapanRecruiting
Dong-A University Medical Center /ID# 279610
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BusanSouth KoreaRecruiting
Chonnam National University Hwasun Hospital /ID# 279787
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Hwasun-gunSouth KoreaRecruiting
Gachon University Gil Medical Center /ID# 279592
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IncheonSouth KoreaRecruiting
CHA Bundang Medical Center /ID# 279589
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SeongnamSouth KoreaRecruiting
Asan Medical Center /ID# 282732
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SeoulSouth KoreaRecruiting
Seoul National University Hospital /ID# 282730
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SeoulSouth KoreaRecruiting
The Catholic University Of Korea St. Vincent's Hospital /ID# 279675
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SuwonSouth KoreaRecruiting
Unidade Local De Saude De Almada-Seixal E.P.E.
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AlmadaPortugalRecruiting
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Unidade Local De Saude De Loures-Odivelas EPE
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LouresPortugalRecruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalRecruiting
E-Da Cancer Hospital /ID# 279745
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Kaohsiung CityTaiwanRecruiting
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708
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New Taipei CityTaiwanRecruiting
Chi Mei Medical Center /ID# 279710
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TainanTaiwanRecruiting
Tri-Service General Hospital - Neihu Branch /ID# 279768
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TaipeiTaiwanRecruiting
Taipei Municipal Wan Fang Hospital /ID# 280285
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TaipeiTaiwanRecruiting
Taipei Medical University Hospital /ID# 280607
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TaipeiTaiwanRecruiting
Texas Oncology - Abilene - Antilley Road /ID# 280120
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AbileneUnited StatesRecruiting
Rocky Mountain Cancer Centers - Aurora /ID# 280112
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AuroraUnited StatesRecruiting
Blue Ridge Cancer Care - Blacksburg /ID# 280115
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BlacksburgUnited StatesRecruiting
University of Chicago Medical Center /ID# 279365
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ChicagoUnited StatesRecruiting
Oncology Hematology Care - Blue Ash /ID# 280143
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CincinnatiUnited StatesRecruiting
City of Hope National Medical Center /ID# 279449
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DuarteUnited StatesRecruiting
Duke University Medical Center /ID# 279322
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DurhamUnited StatesRecruiting
Astera Cancer Care /ID# 279532
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East BrunswickUnited StatesRecruiting
City Of Hope - Phoenix /ID# 279450
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GoodyearUnited StatesRecruiting
The University of Texas MD Anderson Cancer Center /ID# 279865
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HoustonUnited StatesRecruiting
Saint Lukes Hospital of Kansas City /ID# 279513
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Kansas CityUnited StatesRecruiting
Northwell Health Center for Advanced Medicine. /ID# 279590
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Lake SuccessUnited StatesRecruiting
Yale University School of Medicine /ID# 279373
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New HavenUnited StatesRecruiting
City Of Hope - Atlanta /ID# 280017
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NewnanUnited StatesRecruiting
Compass Oncology - Rose Quarter /ID# 280127
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PortlandUnited StatesRecruiting
University Of Washington /ID# 281451
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SeattleUnited StatesRecruiting
Highlands Oncology Group - Springdale /ID# 279444
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SpringdaleUnited StatesRecruiting
Moffitt Cancer Center /ID# 279325
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TampaUnited StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.