A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)
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).
Checked against the public recordLast updated May 28, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Amgen
- Interventions being studied
- Drug: anvumetostat
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of Hope National Medical CenterDuarte, California
- City of Hope Orange County Lennar Foundation Cancer CenterDuarte, California
- Cedars-Sinai Medical CenterLos Angeles, California
- Valkyrie Clinical TrialsLos Angeles, California
- University of California Los AngelesLos Angeles, California
- Rocky Mountain Cancer CentersDenver, Colorado
- Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut
- Hartford HealthCare Cancer Institute - ManchesterPlainville, Connecticut
- Medstar Georgetown University HospitalWashington D.C., District of Columbia
- Our Lady of the Lake Cancer InstituteBaton Rouge, Louisiana
- Trinity Health Saint Joseph Mercy Ann ArborAnn Arbor, Michigan
- Cancer and Hematology Centers of Western MichiganGrand Rapids, Michigan
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 28, 2026. Always confirm current availability with the study team.