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