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

NCT06593522 · tracked via the Priya Life Science China tracker

Sponsor

Amgen

Phase

Phase 2

Started

2024-12-26

Last updated

2026-05-28

Condition(s) studied

MTAP-deleted NSCLC

Investigational drug(s) / intervention(s)

anvumetostat →

anvumetostat: Film-coated tablet

Study summary

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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

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.

Primary outcome measure(s)

Objective Response (OR) per RECIST 1.1 — Up to 35 months
Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1) — Up to 35 months
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) — Up to 35 months
Number of Participants Experiencing Events of Interest (EOIs) — Up to 35 months
Maximum Concentration (Cmax) of anvumetostat — Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Time to Cmax (Tmax) of anvumetostat — Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose
Area Under The Concentration-time Curve (AUC) of anvumetostat — Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

Trial sites (91)

Facility	City	Region
City of Hope National Medical Center	Duarte	California
City of Hope Orange County Lennar Foundation Cancer Center	Duarte	California
Cedars-Sinai Medical Center	Los Angeles	California
Valkyrie Clinical Trials	Los Angeles	California
University of California Los Angeles	Los Angeles	California
Rocky Mountain Cancer Centers	Denver	Colorado
Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
Hartford HealthCare Cancer Institute - Manchester	Plainville	Connecticut
Medstar Georgetown University Hospital	Washington D.C.	District of Columbia
Our Lady of the Lake Cancer Institute	Baton Rouge	Louisiana
Trinity Health Saint Joseph Mercy Ann Arbor	Ann Arbor	Michigan
Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan
Sarah Cannon Research Institute Oncology Partners	Nashville	Tennessee
United States Oncology Regulatory Affairs Corporate Office	Nashville	Tennessee
Texas Oncology Central/South Texas	Austin	Texas
Sarah Cannon Research Institute	Dallas	Texas
Texas Oncology - Dallas Fort Worth	Dallas	Texas
US Oncology Research Investigational Products Center	Irving	Texas
Texas Oncology Northeast Texas	Tyler	Texas
Virginia Cancer Specialists PC	Fairfax	Virginia
GenesisCare -North Shore Oncology	St Leonards	New South Wales
Calvary Mater Newcastle Hospital	Waratah	New South Wales
Mater Hospital Brisbane	South Brisbane	Queensland
Cancer Research South Australia	Adelaide	South Australia
Núcleo de Oncologia da Bahia	Salvador	Estado de Bahia
Liga Norte-Riograndense Contra O Cancer	Natal	Rio Grande do Norte
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul	Porto Alegre	Rio Grande do Sul
Hospital Nossa Senhora da Conceicao	Porto Alegre	Rio Grande do Sul
Fundacao pio xII Barretos	Barretos	São Paulo
Fund Faculdade Regional Med Sao Jose Rio Preto	São José do Rio Preto	São Paulo
Instituto do Cancer Estado SP Icesp	São Paulo	São Paulo
Fundacao Antonio Prudente - Hosp AC Camargo	São Paulo	São Paulo
Instituto de Educacao Pesquisa e Gestao em Saude	Rio de Janeiro	Brazil
Centro Paulista de Oncologia	São Paulo	Brazil
Cross Cancer Institute	Edmonton	Alberta
William Osler Health System - Brampton Civic Hospital	Brampton	Ontario
London Health Sciences Centre	London	Ontario
Princess Margaret Cancer Centre	Toronto	Ontario
McGill University Health Centre Glen Site	Montreal	Quebec
Beijing Cancer Hospital	Beijing	Beijing Municipality

+ 51 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06593522 on ClinicalTrials.gov ↗ ← All trials in China