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Recruiting Phase 2 NCT06593522

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

Phase 2 – studying effectiveness and dosage
Conditions: MTAP-deleted NSCLC

Sponsor: Amgen

trial.available_in: БГ
Overview
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).
Who can participate
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.
Locations 16
Australia (1)
GenesisCare -North Shore Oncology
St Leonards , New South Wales
Brazil (1)
Núcleo de Oncologia da Bahia
Salvador , Estado de Bahia
Canada (1)
Cross Cancer Institute
Edmonton , Alberta
China (1)
Beijing Cancer Hospital
Beijing , Beijing Municipality
Czech Republic (1)
Masarykuv onkologicky ustav
Brno
Hong Kong (1)
Queen Mary Hospital, The University of Hong Kong
Hong Kong
Japan (1)
Aichi Cancer Center
Nagoya , Aichi-ken
Latvia (1)
Pauls Stradins Clinical University Hospital
Riga
Netherlands (1)
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam
Portugal (1)
Unidade Local de Saude de Braga, EPE
Braga
Singapore (1)
National University Hospital
Singapore
South Korea (1)
Cha Bundang Medical Center, Cha University
Seongnam-si, Gyeonggi-do
Switzerland (1)
Universitaetsspital Basel
Basel
Taiwan (1)
Taichung Veterans General Hospital
Taichung
Turkey (1)
Adana Sehir Egitim ve Arastirma Hastanesi
Adana
United States (1)
City of Hope National Medical Center
Duarte , California
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
26.12.2024
Completion date
29.11.2030
Registry ID
NCT06593522
Source
anzctr
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