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 (NCT07525206)
π©Ί Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (4 items).
Location: Astera Cancer Care /ID# 279532 β East Brunswick, New Jersey
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
π Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
π All Participating Trial Locations (35 Sites)
- Astera Cancer Care /ID# 279532 β East Brunswick, New Jersey
- Northwell Health Center for Advanced Medicine. /ID# 279590 β Lake Success, New York
- Compass Oncology - Rose Quarter /ID# 280127 β Portland, Oregon
- University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451 β Seattle, Washington
- Imelda Ziekenhuis /ID# 279333 β Bonheiden, Antwerpen
- Algemeen Ziekenhuis klina /ID# 279331 β Brasschaat, Antwerpen
- Universitair Ziekenhuis Antwerpen /ID# 279334 β Edegem, Antwerpen
- Institut Jules Bordet /ID# 279406 β Anderlecht, Brussels Capital
- Grand Hopital de Charleroi - Les Viviers /ID# 279336 β Charleroi, Hainaut
- AZ Maria Middelares /ID# 280141 β Ghent, Oost-Vlaanderen
- AZ-Delta. /ID# 279329 β Roeselare, West-Vlaanderen
- Athens Medical Center - Psychikon Branch /ID# 279134 β Athens, Attica
- National Cancer Center Hospital East /ID# 279917 β Kashiwa-shi, Chiba
- National Hospital Organization Shikoku Cancer Center /ID# 280224 β Matsuyama, Ehime
- Kobe City Medical Center General Hospital /ID# 280233 β Kobe, HyΕgo
- Unidade Local de Saude do Alto Ave, EPE /ID# 279703 β GuimarΓ£es, Braga District
- Unidade Local de Saude de Loures-Odivelas /ID# 279636 β Loures, Lisbon District
- Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637 β Almada, SetΓΊbal District
- Unidade Local de Saude de Santa Maria /ID# 279624 β Lisbon,
- Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702 β Porto,
- Dong-A University Medical Center /ID# 279610 β Busan, Busan Gwang Yeogsi
- Gachon University Gil Medical Center /ID# 279592 β Incheon, Gyeonggido
- CHA Bundang Medical Center /ID# 279589 β Seongnam, Gyeonggido
- The Catholic University Of Korea St. Vincent's Hospital /ID# 279675 β Suwon, Gyeonggido
- Hospital de la Santa Creu i Sant Pau /ID# 279642 β Barcelona,
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.