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A Phase 2 Study of Anvumetostat in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)
NCT06593522 · Amgen
In plain English
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Official title
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)
About this study
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 criteria
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 design
Enrollment target: 200 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-26
Estimated completion: 2030-11-29
Last updated: 2026-04-07
Interventions
Drug: anvumetostat
Primary outcomes
- • 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)
Sponsor
Amgen · industry
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (91)
City of Hope National Medical CenterRecruiting
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer CenterRecruiting
Duarte, California, United States
Cedars-Sinai Medical CenterRecruiting
Los Angeles, California, United States
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
University of California Los AngelesRecruiting
Los Angeles, California, United States
Rocky Mountain Cancer CentersRecruiting
Denver, Colorado, United States
Eastern Connecticut Hematology and Oncology AssociatesRecruiting
Norwich, Connecticut, United States
Hartford HealthCare Cancer Institute - ManchesterRecruiting
Plainville, Connecticut, United States
Medstar Georgetown University HospitalRecruiting
Washington D.C., District of Columbia, United States
Our Lady of the Lake Cancer InstituteRecruiting
Baton Rouge, Louisiana, United States
Trinity Health Saint Joseph Mercy Ann ArborRecruiting
Ann Arbor, Michigan, United States
Cancer and Hematology Centers of Western MichiganRecruiting
Grand Rapids, Michigan, United States
Sarah Cannon Research Institute Oncology PartnersRecruiting
Nashville, Tennessee, United States
United States Oncology Regulatory Affairs Corporate OfficeRecruiting
Nashville, Tennessee, United States
Texas Oncology Central/South TexasRecruiting
Austin, Texas, United States
Sarah Cannon Research InstituteRecruiting
Dallas, Texas, United States
Texas Oncology - Dallas Fort WorthRecruiting
Dallas, Texas, United States
US Oncology Research Investigational Products CenterRecruiting
Irving, Texas, United States
Texas Oncology Northeast TexasRecruiting
Tyler, Texas, United States
Virginia Cancer Specialists PCRecruiting
Fairfax, Virginia, United States
GenesisCare -North Shore OncologyRecruiting
St Leonards, New South Wales, Australia
Calvary Mater Newcastle HospitalRecruiting
Waratah, New South Wales, Australia
Mater Hospital BrisbaneRecruiting
South Brisbane, Queensland, Australia
Cancer Research South AustraliaRecruiting
Adelaide, South Australia, Australia
Núcleo de Oncologia da BahiaRecruiting
Salvador, Estado de Bahia, Brazil
Liga Norte-Riograndense Contra O CancerRecruiting
Natal, Rio Grande do Norte, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do SulRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da ConceicaoRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao pio xII BarretosRecruiting
Barretos, São Paulo, Brazil
Fund Faculdade Regional Med Sao Jose Rio PretoRecruiting
São José do Rio Preto, São Paulo, Brazil
Instituto do Cancer Estado SP IcespRecruiting
São Paulo, São Paulo, Brazil
Fundacao Antonio Prudente - Hosp AC CamargoRecruiting
São Paulo, São Paulo, Brazil
Instituto de Educacao Pesquisa e Gestao em SaudeRecruiting
Rio de Janeiro, Brazil
Centro Paulista de OncologiaRecruiting
São Paulo, Brazil
Cross Cancer InstituteRecruiting
Edmonton, Alberta, Canada
William Osler Health System - Brampton Civic HospitalRecruiting
Brampton, Ontario, Canada
London Health Sciences CentreRecruiting
London, Ontario, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
McGill University Health Centre Glen SiteRecruiting
Montreal, Quebec, Canada
Beijing Cancer HospitalRecruiting
Beijing, Beijing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical UniversityRecruiting
Fuzhou, Fujian, China
Henan Cancer HospitalRecruiting
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou UniversityRecruiting
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan, China
Jilin Cancer HospitalRecruiting
Changchun, Jilin, China
Jinan Central HospitalRecruiting
Jinan, Shandong, China
Shanghai East HospitalRecruiting
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan UniversityRecruiting
Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University School Of MedicineRecruiting
Hangzhou, Zhejiang, China
Zhejiang Cancer HospitalRecruiting
Hangzhou, Zhejiang, China
Beijing Cancer HospitalRecruiting
Beijing, China
Beijing Chest Hospital, Capital Medical UniversityRecruiting
Beijing, China
Masarykuv onkologicky ustavRecruiting
Brno, Czechia
Fakultni nemocnice OlomoucRecruiting
Olomouc, Czechia
Vseobecna fakultni nemocnice v PrazeRecruiting
Prague, Czechia
Fakultni Thomayerova nemocniceRecruiting
Prague, Czechia
Queen Mary Hospital, The University of Hong KongRecruiting
Hong Kong, Hong Kong
Prince of Wales Hospital, Chinese University of Hong KongRecruiting
Shatin, New Territories, Hong Kong
Aichi Cancer CenterRecruiting
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital EastRecruiting
Kashiwa-shi, Chiba, Japan
Shizuoka Cancer CenterRecruiting
Sunto-gun, Shizuoka, Japan
National Cancer Center HospitalRecruiting
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
Koto-ku, Tokyo, Japan
Wakayama Medical University HospitalRecruiting
Wakayama, Wakayama, Japan
Pauls Stradins Clinical University HospitalRecruiting
Riga, Latvia
Riga East Clinical University HospitalRecruiting
Riga, Latvia
Nederlands Kanker Instituut Antoni van LeeuwenhoekziekenhuisRecruiting
Amsterdam, Netherlands
Sint Jansdal ZiekenhuisRecruiting
Harderwijk, Netherlands
Erasmus Medisch CentrumRecruiting
Rotterdam, Netherlands
Unidade Local de Saude de Braga, EPERecruiting
Braga, Portugal
Fundacao ChampalimaudRecruiting
Lisbon, Portugal
Hospital Cuf portoRecruiting
Porto, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPERecruiting
Porto, Portugal
National University HospitalRecruiting
Singapore, Singapore
National Cancer Centre SingaporeRecruiting
Singapore, Singapore
Cha Bundang Medical Center, Cha UniversityRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
Seoul, South Korea
Ajou University HospitalRecruiting
Suwon-si Gyeonggi-do, South Korea
The Catholic University of Korea St Vincents HospitalRecruiting
Suwon-si, Gyeonggi-do, South Korea
Universitaetsspital BaselRecruiting
Basel, Switzerland
Hopitaux Universitaires de GeneveRecruiting
Geneva, Switzerland
Kantonsspital Sankt GallenRecruiting
Sankt Gallen, Switzerland
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Adana Sehir Egitim ve Arastirma HastanesiRecruiting
Adana, Turkey (Türkiye)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi HastanesiRecruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir HastanesiRecruiting
Ankara, Turkey (Türkiye)
Memorial Bahcelievler HastanesiRecruiting
Istanbul, Turkey (Türkiye)
Bagcilar Medipol Mega Universite HastanesiRecruiting
Istanbul, Turkey (Türkiye)