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

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Anvumetostat in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: MTAP-deleted NSCLC
• Intervention / Treatment: Drug: anvumetostat

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
      • GenesisCare -North Shore Oncology
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Hospital Brisbane
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Cancer Research South Australia
• Brazil
  • Rio de Janeiro, Brazil, 22775-001
    • Instituto de Educacao Pesquisa e Gestao em Saude
  • São Paulo, Brazil, 04538-132
    • Centro Paulista de Oncologia
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40170-110
      • Nucleo de Oncologia da Bahia
  • Rio Grande do Norte
    • Natal, Rio Grande do Norte, Brazil, 59062-000
      • Liga Norte-Riograndense Contra O Cancer
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 91010-004
      • Hospital Nossa Senhora da Conceicao
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784-400
      • Fundacao pio xII Barretos
    • São José do Rio Preto, São Paulo, Brazil, 15090-000
      • Fund Faculdade Regional Med Sao Jose Rio Preto
    • São Paulo, São Paulo, Brazil, 01246-000
      • Instituto do Cancer Estado SP Icesp
    • São Paulo, São Paulo, Brazil, 01509-900
      • Fundacao Antonio Prudente - Hosp AC Camargo
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • William Osler Health System - Brampton Civic Hospital
    • London, Ontario, Canada, N6A 4L6
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre Glen Site
• China
  • Beijing, China, 101149
    • Beijing Chest Hospital, Capital Medical University
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Beijing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350028
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Henan
    • Zhengzhou, Henan, China, 450052
      • the First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450001
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital of Central South University
  • Jilin
    • Changchun, Jilin, China, 130012
      • Jilin Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200123
      • Shanghai East Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310005
      • Zhejiang Cancer Hospital
• Czechia
  • Brno, Czechia, 656 53
    • Masarykuv onkologicky ustav
  • Olomouc, Czechia, 779 00
    • Fakultni Nemocnice Olomouc
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice V Praze
  • Prague, Czechia, 140 59
    • Fakultni Thomayerova nemocnice
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital, The University of Hong Kong
  • Shatin, New Territories, Hong Kong
    • Prince of Wales Hospital, Chinese University of Hong Kong
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Aichi Cancer Center
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
  • Wakayama
    • Wakayama, Wakayama, Japan, 641-8510
      • Wakayama Medical University Hospital
• Latvia
  • Riga, Latvia, 1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, 1079
    • Riga East Clinical University Hospital
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
  • Harderwijk, Netherlands, 3844 DG
    • Sint Jansdal Ziekenhuis
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medisch Centrum
• Portugal
  • Braga, Portugal, 4710-243
    • Unidade Local de Saude de Braga, EPE
  • Lisbon, Portugal, 1400-038
    • Fundacao Champalimaud
  • Porto, Portugal, 4100-180
    • Hospital CUF Porto
  • Porto, Portugal, 4200-072
    • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 168583
    • National Cancer Centre Singapore
• South Korea
  • Seongnam-si, Gyeonggi-do, South Korea, 13496
    • Cha Bundang Medical Center, Cha University
  • Seoul, South Korea, 03722
    • Severance Hospital Yonsei University Health System
  • Suwon-si Gyeonggi-do, South Korea, 16499
    • Ajou University Hospital
  • Suwon-si, Gyeonggi-do, South Korea, 16247
    • The Catholic University of Korea St Vincents Hospital
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel
  • Geneva, Switzerland, 1211
    • Hôpitaux Universitaires de Genève
  • Sankt Gallen, Switzerland, 9007
    • Kantonsspital Sankt Gallen
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01370
    • Adana Sehir Egitim ve Arastirma Hastanesi
  • Ankara, Turkey (Türkiye), 06800
    • Ankara Bilkent Şehir Hastanesi
  • Ankara, Turkey (Türkiye), 06560
    • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
  • Istanbul, Turkey (Türkiye), 34214
    • Bagcilar Medipol Mega Universite Hastanesi
  • Istanbul, Turkey (Türkiye), 34180
    • Memorial Bahcelievler Hastanesi
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope National Medical Center
    • Duarte, California, United States, 91010
      • City of Hope Orange County Lennar Foundation Cancer Center
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials
  • Colorado
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology and Oncology Associates
    • Plainville, Connecticut, United States, 06062
      • Hartford HealthCare Cancer Institute - Manchester
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Trinity Health Saint Joseph Mercy Ann Arbor
    • Grand Rapids, Michigan, United States, 49503
      • Cancer and Hematology Centers of Western Michigan
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • United States Oncology Regulatory Affairs Corporate Office
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute Oncology Partners
  • Texas
    • Austin, Texas, United States, 78745
      • Texas Oncology Central/South Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Dallas Fort Worth
    • Dallas, Texas, United States, 75230
      • Sarah Cannon Research Institute
    • Irving, Texas, United States, 75063
      • US Oncology Research Investigational Products Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology Northeast Texas
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose Evaluation; Participants will be randomized to receive one of 2 active dose levels of anvumetostat orally (PO) daily (QD) in 28 days cycles. Part 1 of the study will determine the recommended phase 2 dose (RP2D).	Drug: anvumetostat; Film-coated tablet
Experimental: Part 2: Dose Expansion; Participants will receive anvumetostat PO QD in 28-day cycles at the RP2D.	Drug: anvumetostat; Film-coated tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	Up to 35 months
Disease Control (DC) by BICR	Up to 35 months
Duration of Response (DOR) by BICR	Up to 35 months
Time to Response (TTR) by BICR	Up to 35 months
Progression-free Survival (PFS) by BICR	Up to 35 months
OR by Investigator's Assessment	Up to 35 months
DC by Investigator's Assessment	Up to 35 months
DOR by Investigator's Assessment	Up to 35 months
TTR by Investigator's Assessment	Up to 35 months
PFS by Investigator's Assessment	Up to 35 months
Number of Participants Experiencing TEAEs	Up to 35 months
Change in Quality of life (QoL) per The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ)-C30	Up to 12 months
Change in QoL per Quality of Life Questionnaire-Lung Cancer 13 (QLQ LC13)	Up to 12 months
Change in QoL per European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)	Up to 12 months
Overall Health Status per Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)	Up to 12 months
Overall Health Status per The Functional Assessment of Cancer Therapy - General (FACT-G)	Up to 12 months
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
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
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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Oncology; anvumetostat
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms
• Other Study ID Numbers: 20230153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No