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Набира участници Фаза 2 NCT06593522

A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: MTAP-deleted NSCLC

Спонсор: Amgen

Налично на: БГ
Обобщение
The main objective of the study is to characterize safety and efficacy of 2 dose levels of anvumetostat by investigator, and to evaluate anvumetostat monotherapy efficacy by Blinded Independent Central Review (BICR).
Кой може да участва
Inclusion Criteria: * Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC * Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease. * Either an archival tissue sample or an archival block must be available. * Life expectancy of greater than 3 months, in the opinion of the investigator. * Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible. * Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible. Exclusion Criteria: Disease Related • Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2/ERBB2), KRAS proto-oncogene G12C (KRAS G12C). Other Medical Conditions * Major surgery within 28 days of study day 1. * Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.
Места на провеждане 16
Австралия (1)
GenesisCare -North Shore Oncology
St Leonards , New South Wales
Бразилия (1)
Núcleo de Oncologia da Bahia
Salvador , Estado de Bahia
Канада (1)
Cross Cancer Institute
Edmonton , Alberta
Китай (1)
Beijing Cancer Hospital
Beijing , Beijing Municipality
Чехия (1)
Masarykuv onkologicky ustav
Brno
Hong Kong (1)
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Япония (1)
Aichi Cancer Center
Nagoya , Aichi-ken
Latvia (1)
Pauls Stradins Clinical University Hospital
Riga
Нидерландия (1)
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam
Португалия (1)
Unidade Local de Saude de Braga, EPE
Braga
Сингапур (1)
National University Hospital
Singapore
Южна Корея (1)
Cha Bundang Medical Center, Cha University
Seongnam-si, Gyeonggi-do
Швейцария (1)
Universitaetsspital Basel
Basel
Taiwan (1)
Taichung Veterans General Hospital
Taichung
Турция (1)
Adana Sehir Egitim ve Arastirma Hastanesi
Adana
САЩ (1)
City of Hope National Medical Center
Duarte , California
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
99 Years
Здрави доброволци
Не
Начална дата
26.12.2024
Крайна дата
29.11.2030
Регистрационен номер
NCT06593522
Източник
anzctr
Запитване за медицински туризъм

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