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Набира участници Фаза 2 NCT06820463

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

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Metastatic Colorectal Cancer

Спонсор: AbbVie

Налично на: БГ
Обобщение
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.
Кой може да участва
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Места на провеждане 11
Австралия (1)
Macquarie University /ID# 271514
Sydney , New South Wales
Бразилия (1)
ONCOSITE - Centro de Pesquisa Clinica em Oncologia /ID# 270147
Ijuí , Rio Grande do Sul
Чехия (1)
Fakultní nemocnice Hradec Králové - Sokolská /ID# 268773
Hradec Králové , Hradec Kralove
Франция (1)
Chu De Lille - Hopital Claude Huriez /ID# 270222
Lille , Hauts-de-France
Гърция (1)
St. Luke's Hospital S.A. /ID# 269963
Panórama , Thessaloniki
Израел (1)
Tel Aviv Sourasky Medical Center /ID# 268010
Tel Aviv , Tel Aviv
Япония (1)
Aichi Cancer Center /ID# 270113
Nagoya , Aichi-ken
Puerto Rico (1)
Pan American Center for Oncology Trials /ID# 268809
Rio Piedras
Испания (1)
Hospital Universitario Marques de Valdecilla /ID# 269732
Santander , Cantabria
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital /ID# 269726
Kaohsiung City , Kaohsiung
САЩ (1)
City of Hope National Medical Center /ID# 270255
Duarte , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
24.04.2025
Крайна дата
01.04.2028
Регистрационен номер
NCT06820463
Източник
anzctr
Запитване за медицински туризъм

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