RecruitingPhase 3NCT07525206

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


Sponsor

AbbVie

Enrollment

700 participants

Start Date

May 22, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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.

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Interventions

DRUGTelisotuzumab adizutecan

Intravenous (IV)

DRUGBevacizumab

Intravenous (IV)

DRUGTrifluridine/Tipiracil

Oral


Locations(6)

Algemeen Ziekenhuis klina /ID# 279331

Brasschaat, Antwerpen, Belgium

National Cancer Center Hospital East /ID# 279917

Kashiwa-shi, Chiba, Japan

Taipei Medical University Hospital /ID# 280607

Taipei, Tainan, Taiwan

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

New Taipei City, Taiwan

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

Taipei, Taiwan

Taipei Municipal Wan Fang Hospital /ID# 280285

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07525206


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