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

Recruiting now · Phase 3

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT07525206

Run by

AbbVie

People needed

700

Starts

2026-05-22

Expected to finish

2030-03-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Taipei Municipal Wan Fang Hospital /ID# 280285 — Taipei, Taiwan (enrolling)
• Northwell Health Center for Advanced Medicine. /ID# 279590 — Lake Success, New York, United States (enrolling)
• Compass Oncology - Rose Quarter /ID# 280127 — Portland, Oregon, United States (enrolling)
• University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451 — Seattle, Washington, United States (enrolling)
• Imelda Ziekenhuis /ID# 279333 — Bonheiden, Antwerpen, Belgium (enrolling)
• Astera Cancer Care /ID# 279532 — East Brunswick, New Jersey, United States (enrolling)
• Universitair Ziekenhuis Antwerpen /ID# 279334 — Edegem, Antwerpen, Belgium (enrolling)
• Institut Jules Bordet /ID# 279406 — Anderlecht, Brussels Capital, Belgium (enrolling)
• Grand Hopital de Charleroi - Les Viviers /ID# 279336 — Charleroi, Hainaut, Belgium (enrolling)
• AZ Maria Middelares /ID# 280141 — Ghent, Oost-Vlaanderen, Belgium (enrolling)
• AZ-Delta. /ID# 279329 — Roeselare, West-Vlaanderen, Belgium (enrolling)
• Athens Medical Center - Psychikon Branch /ID# 279134 — Athens, Attica, Greece (enrolling)
• National Cancer Center Hospital East /ID# 279917 — Kashiwa-shi, Chiba, Japan (enrolling)
• National Hospital Organization Shikoku Cancer Center /ID# 280224 — Matsuyama, Ehime, Japan (enrolling)
• Kobe City Medical Center General Hospital /ID# 280233 — Kobe, Hyōgo, Japan (enrolling)
• Unidade Local de Saude do Alto Ave, EPE /ID# 279703 — Guimarães, Braga District, Portugal (enrolling)
• Unidade Local de Saude de Loures-Odivelas /ID# 279636 — Loures, Lisbon District, Portugal (enrolling)
• Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637 — Almada, Setúbal District, Portugal (enrolling)
• Unidade Local de Saude de Santa Maria /ID# 279624 — Lisbon, Portugal (enrolling)
• Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702 — Porto, Portugal (enrolling)
• Dong-A University Medical Center /ID# 279610 — Busan, Busan Gwang Yeogsi, South Korea (enrolling)
• Gachon University Gil Medical Center /ID# 279592 — Incheon, Gyeonggido, South Korea (enrolling)
• CHA Bundang Medical Center /ID# 279589 — Seongnam, Gyeonggido, South Korea (enrolling)
• The Catholic University Of Korea St. Vincent's Hospital /ID# 279675 — Suwon, Gyeonggido, South Korea (enrolling)
• Hospital de la Santa Creu i Sant Pau /ID# 279642 — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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