Tests telisotuzumab adizutecan with bevacizumab in colorectal cancer that stopped responding
Compares a new drug with bevacizumab against standard treatment in adults with colorectal cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Berlin, Bonn, Dresden, Essen, Frankfurt Am Main, Hamburg, Heidelberg, Mainz, Munich, and Reutlingen, GermanySee the 10 sites
- Phase
- Phase 3
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
- Gemeinschaftspraxis Haematologie OnkologieDresden, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Goethe University FrankfurtFrankfurt Am Main, GermanyTaking people
- Asklepios Kliniken Hamburg GmbHHamburg, GermanyTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
- LMU Klinikum Muenchen AöRMunich, GermanyTaking people
- Kreiskliniken Reutlingen gGmbHReutlingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie
- Trial code
- NCT07525206EU 2025-521712-19-00
- Record updated
- 19 October 2026
- Original description
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).Read full original descriptionShow less
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.
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.
Inclusion: 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: Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any Top-1 inhibitor ADC; 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; 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.