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

Running, not enrolling · Phase 2

Conditions studied: MTAP-deleted NSCLC

In brief

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).

Key facts

Study ID

NCT06593522

Run by

Amgen

People needed

61

Starts

2024-12-26

Expected to finish

2026-11-30

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope Orange County Lennar Foundation Cancer Center — Duarte, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Valkyrie Clinical Trials — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States
• Hartford HealthCare Cancer Institute - Manchester — Plainville, Connecticut, United States
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Our Lady of the Lake Cancer Institute — Baton Rouge, Louisiana, United States
• Trinity Health Saint Joseph Mercy Ann Arbor — Ann Arbor, Michigan, United States
• Cancer and Hematology Centers of Western Michigan — Grand Rapids, Michigan, United States
• Sarah Cannon Research Institute Oncology Partners — Nashville, Tennessee, United States
• United States Oncology Regulatory Affairs Corporate Office — Nashville, Tennessee, United States
• Texas Oncology Central/South Texas — Austin, Texas, United States
• Sarah Cannon Research Institute — Dallas, Texas, United States
• Texas Oncology - Dallas Fort Worth — Dallas, Texas, United States
• US Oncology Research Investigational Products Center — Irving, Texas, United States
• Texas Oncology Northeast Texas — Tyler, Texas, United States
• Virginia Cancer Specialists PC — Fairfax, Virginia, United States
• GenesisCare -North Shore Oncology — St Leonards, New South Wales, Australia
• Calvary Mater Newcastle Hospital — Waratah, New South Wales, Australia
• Mater Hospital Brisbane — South Brisbane, Queensland, Australia
• Cancer Research South Australia — Adelaide, South Australia, Australia
• Núcleo de Oncologia da Bahia — Salvador, Estado de Bahia, Brazil
• City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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