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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Telisotuzumab adizutecan
  Intravenous (IV)
• Препарат Bevacizumab
  Intravenous (IV)
• Препарат Trifluridine/Tipiracil
  Oral

Первичные конечные точки

• Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to Approximately 15 Months]
• Phase 3: Overall Survival (OS) [Срок оценки: Up to Approximately 36 Months]

Вторичные конечные точки (5)

• Phase 3: Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to Approximately 24 Months]
• Phase 3: Duration Of Response (DoR) as assessed by BICR [Срок оценки: Up to Approximately 24 Months]
• Phase 3: Disease Control (DC) as assessed by BICR: [Срок оценки: Up to Approximately 24 Months]
• Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domain at Week 13 [Срок оценки: Up to Approximately 13 Weeks]
• Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains [Срок оценки: Up to Approximately 13 Weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 7 центров

• Imelda Ziekenhuis /ID# 279333 — Bonheiden
• Algemeen Ziekenhuis klina /ID# 279331 — Brasschaat
• Universitair Ziekenhuis Antwerpen /ID# 279334 — Edegem
• Institut Jules Bordet /ID# 279406 — Anderlecht
• Grand Hopital de Charleroi - Les Viviers /ID# 279336 — Charleroi
• AZ Maria Middelares /ID# 280141 — Ghent
• AZ-Delta. /ID# 279329 — Roeselare

Тайвань · 6 центров

• Taipei Medical University Hospital /ID# 280607 — Taipei
• E-Da Cancer Hospital /ID# 279745 — Kaohsiung City
• Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare /ID# 279708 — New Taipei City
• Chi Mei Medical Center /ID# 279710 — Tainan
• Tri-Service General Hospital - Neihu Branch /ID# 279768 — Taipei
• Taipei Municipal Wan Fang Hospital /ID# 280285 — Taipei

Португалия · 5 центров

• Unidade Local de Saude do Alto Ave, EPE /ID# 279703 — Guimarães
• Unidade Local de Saude de Loures-Odivelas /ID# 279636 — Loures
• Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637 — Almada
• Unidade Local de Saude de Santa Maria /ID# 279624 — Lisbon
• Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702 — Porto

Испания · 5 центров

• Hospital de la Santa Creu i Sant Pau /ID# 279642 — Barcelona
• Hospital General Universitario Gregorio Maranon /ID# 279650 — Madrid
• Hospital Universitario 12 de Octubre /ID# 279659 — Madrid
• Hospital Universitario La Paz /ID# 279664 — Madrid
• Hospital Clinico Universitario de Valencia /ID# 279645 — Valencia

США · 4 центра

• Astera Cancer Care /ID# 279532 — East Brunswick
• Northwell Health Center for Advanced Medicine. /ID# 279590 — Lake Success
• Compass Oncology - Rose Quarter /ID# 280127 — Portland
• University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451 — Seattle

South Korea · 4 центра

• Dong-A University Medical Center /ID# 279610 — Busan
• Gachon University Gil Medical Center /ID# 279592 — Incheon
• CHA Bundang Medical Center /ID# 279589 — Seongnam
• The Catholic University Of Korea St. Vincent's Hospital /ID# 279675 — Suwon

Япония · 3 центра

• National Cancer Center Hospital East /ID# 279917 — Kashiwa-shi
• National Hospital Organization Shikoku Cancer Center /ID# 280224 — Matsuyama
• Kobe City Medical Center General Hospital /ID# 280233 — Kobe

Греция · 1 центр

• Athens Medical Center - Psychikon Branch /ID# 279134 — Athens

Идентификаторы

NCT: NCT07525206 · M24-560 · 2025-521712-19-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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