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Clinical Trials in Australia / NCT06593522
Active, not recruiting Phase 2

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

NCT06593522 · tracked via the Priya Life Science Australia 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
No
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)

FacilityCityRegionStatus
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 Australia