A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer

Официальное название

A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer

Обзор

CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years. 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) Infusion
• Препарат Fluorouracil
  IV Infusion; IV Injection
• Препарат Oxaliplatin
  IV Infusion
• Препарат Leucovorin
  IV Infusion; IV Injection
• Препарат Bevacizumab
  IV Infusion
• Препарат Panitumumab
  IV Infusion

Первичные конечные точки

• Objective Response (OR) as Assessed by the Investigator confirmed complete response (CR) or partial response (PR) as assessed by the investigator per response evaluation criteria in solid tumors (RECIST), version 1.1. [Срок оценки: Up to 24 Weeks]
• Number of Participants with Adverse Events (AE)s [Срок оценки: Up to Approximately 6 Years]

Вторичные конечные точки (4)

• Progression-Free Survival (PFS) as Assessed by the Investigator [Срок оценки: Up to 22 Months]
• Duration of Response (DOR) as Assessed by the investigator [Срок оценки: Up to 14 Months]
• Overall Survival (OS) [Срок оценки: Up to Approximately 6 Years]
• Disease Control (DC) as Assessed by the Investigator [Срок оценки: Up to Approximately 6 Years]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Laboratory values meeting the criteria within the protocol.
• Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.

Критерии исключения

• Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan).
• History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.

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

США · 16 центров

• City of Hope National Medical Center /ID# 270255 — Duarte
• UCLA - Santa Monica /ID# 270621 — Santa Monica
• Yale New Haven Hospital /ID# 270565 — New Haven
• Northwest Georgia Oncology Centers /ID# 270245 — Marietta
• University of Chicago Medical Center /ID# 271688 — Chicago
• Hope And Healing Cancer Services /ID# 271562 — Hinsdale
• Dana-Farber Cancer Institute /ID# 270624 — Boston
• University Of Michigan /ID# 270790 — Ann Arbor
• … и ещё 8 центров

Бразилия · 6 центров

• Hospital Sao Rafael /ID# 271681 — Salvador
• Oncosite - Centro de Pesquisa Clinica em Oncologia /ID# 270147 — Ijuí
• Hospital De Amor /ID# 271874 — Barretos
• Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 271651 — São José do Rio Preto
• Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 270546 — São Paulo
• Nucleo De Pesquisa Clinica Da Rede Sao Camilo /ID# 272311 — São Paulo

Тайвань · 6 центров

• Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 269724 — Kaohsiung City
• Kaohsiung Chang Gung Memorial Hospital /ID# 269726 — Kaohsiung City
• National Cheng Kung University Hospital /ID# 270835 — Tainan
• National Taiwan University Hospital /ID# 269717 — Taipei
• Taipei Veterans General Hospital /ID# 269718 — Taipei
• Linkou Chang Gung Memorial Hospital /ID# 269725 — Taoyuan City

Австралия · 5 центров

• Macquarie University /ID# 271514 — Sydney
• Mater Hospital Brisbane /ID# 270694 — South Brisbane
• The Queen Elizabeth Hospital /ID# 270693 — Woodville South
• Austin Health /ID# 270692 — Heidelberg
• One Clinical Research /ID# 270695 — Nedlands

Израиль · 5 центров

• Rabin Medical Center. /ID# 268008 — Petah Tikva
• Tel Aviv Sourasky Medical Center /ID# 268010 — Tel Aviv
• Rambam Health Care Campus- Haifa /ID# 268006 — Haifa
• Shaare Zedek Medical Center /ID# 268009 — Jerusalem
• Hadassah Medical Center-Hebrew University /ID# 268007 — Jerusalem

Япония · 5 центров

• Aichi Cancer Center /ID# 270113 — Nagoya
• National Cancer Center Hospital East /ID# 270114 — Kashiwa-shi
• St Marianna University School Of Medicine /ID# 270111 — Kawasaki-shi
• Tohoku University Hospital /ID# 270966 — Sendai
• National Cancer Center Hospital /ID# 270112 — Chuo-Ku

Канада · 3 центра

• Arthur J.E Child Comprehensive Cancer Centre /ID# 269809 — Calgary
• London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270680 — London
• Princess Margaret Cancer Centre /ID# 268715 — Toronto

Франция · 3 центра

• Chu De Lille - Hopital Claude Huriez /ID# 270222 — Lille
• Centre Hospitalier Universitaire de Poitiers /ID# 270225 — Poitiers
• Hopital Europeen Georges Pompidou /ID# 270224 — Paris

Чехия · 2 центра

• Fakultni Thomayerova nemocnice /ID# 269632 — Prague
• Fakultni nemocnice Hradec Kralove - Sokolska /ID# 268773 — Hradec Králové

Греция · 2 центра

• St. Luke's Hospital /ID# 269963 — Panórama
• Theagenio Cancer Hospital /ID# 269640 — Thessaloniki

Пуэрто-Рико · 2 центра

• Pan American Center for Oncology Trials - Rio Piedras /ID# 268809 — Rio Piedras
• Puerto Rico Medical Research Center /ID# 268825 — San Juan

Испания · 2 центра

• Hospital Universitario Marques de Valdecilla /ID# 269732 — Santander
• Hospital Universitario Vall de Hebron /ID# 270191 — Barcelona

Австрия · 1 центр

• Medizinische Universitaet Wien /ID# 268872 — Vienna

Великобритания · 1 центр

• The Royal Marsden - Sutton /ID# 271172 — Sutton

Идентификаторы

NCT: NCT06820463 · M24-533 · EU CT · 2024-512981-33-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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