RecruitingPhase 2NCT06593522

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)

Sponsor

Amgen

Enrollment

200 participants

Start Date

Dec 26, 2024

Study Type

INTERVENTIONAL

Conditions

MTAP-deleted NSCLC

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study is testing a drug called AMG 193 in people with advanced non-small cell lung cancer (NSCLC) that has a specific genetic deletion (loss of the MTAP gene), which makes some cancer cells vulnerable to a new type of attack. **You may be eligible if...** - You have advanced or metastatic non-small cell lung cancer with confirmed loss of the MTAP gene - Your cancer has grown or come back after at least one previous systemic cancer treatment - You have tumor tissue available (from a biopsy or archive) - Your life expectancy is more than 3 months - Brain metastases are allowed if they have been treated and are stable **You may NOT be eligible if...** - Your lung cancer has a different treatable mutation (EGFR, ALK, ROS1, NTRK, MET, BRAF, RET, HER2, or KRAS G12C) - You had major surgery within 28 days before starting treatment - You have active or untreated brain metastases with symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGanvumetostat

Film-coated tablet

Locations(91)

City of Hope National Medical Center

Duarte, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Duarte, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Hartford HealthCare Cancer Institute - Manchester

Plainville, Connecticut, United States

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana, United States

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan, United States

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States

Texas Oncology Central/South Texas

Austin, Texas, United States

Sarah Cannon Research Institute

Dallas, Texas, United States

Texas Oncology - Dallas Fort Worth

Dallas, Texas, United States

US Oncology Research Investigational Products Center

Irving, Texas, United States

Texas Oncology Northeast Texas

Tyler, Texas, United States

Virginia Cancer Specialists PC

Fairfax, Virginia, United States

GenesisCare -North Shore Oncology

St Leonards, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Mater Hospital Brisbane

South Brisbane, Queensland, Australia

Cancer Research South Australia

Adelaide, South Australia, Australia

Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, Brazil

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, Brazil

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao pio xII Barretos

Barretos, São Paulo, Brazil

Fund Faculdade Regional Med Sao Jose Rio Preto

São José do Rio Preto, São Paulo, Brazil

Instituto do Cancer Estado SP Icesp

São Paulo, São Paulo, Brazil

Fundacao Antonio Prudente - Hosp AC Camargo

São Paulo, São Paulo, Brazil

Instituto de Educacao Pesquisa e Gestao em Saude

Rio de Janeiro, Brazil

Centro Paulista de Oncologia

São Paulo, Brazil

Cross Cancer Institute

Edmonton, Alberta, Canada

William Osler Health System - Brampton Civic Hospital

Brampton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

McGill University Health Centre Glen Site

Montreal, Quebec, Canada

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jilin Cancer Hospital

Changchun, Jilin, China

Jinan Central Hospital

Jinan, Shandong, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, China

Beijing Chest Hospital, Capital Medical University

Beijing, China

Masarykuv onkologicky ustav

Brno, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Fakultni Thomayerova nemocnice

Prague, Czechia

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

Pauls Stradins Clinical University Hospital

Riga, Latvia

Riga East Clinical University Hospital

Riga, Latvia

Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

Amsterdam, Netherlands

Sint Jansdal Ziekenhuis

Harderwijk, Netherlands

Erasmus Medisch Centrum

Rotterdam, Netherlands

Unidade Local de Saude de Braga, EPE

Braga, Portugal

Fundacao Champalimaud

Lisbon, Portugal

Hospital Cuf porto

Porto, Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal

National University Hospital

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Cha Bundang Medical Center, Cha University

Seongnam-si, Gyeonggi-do, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Ajou University Hospital

Suwon-si Gyeonggi-do, South Korea

The Catholic University of Korea St Vincents Hospital

Suwon-si, Gyeonggi-do, South Korea

Universitaetsspital Basel

Basel, Switzerland

Hopitaux Universitaires de Geneve

Geneva, Switzerland

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, Turkey (Türkiye)

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

Memorial Bahcelievler Hastanesi

Istanbul, Turkey (Türkiye)

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06593522