RecruitingPhase 1NCT06333951

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol)

Sponsor

Amgen

Enrollment

500 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Thoracic Tumors

Summary

The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of Anvumetostat administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AMG 193, alone or combined with other cancer therapies, in people whose tumors have a specific genetic deletion (MTAP deletion). This genetic change makes certain cancer cells dependent on a pathway that AMG 193 is designed to block. **You may be eligible if...** - You are 18 years of age or older - Your tumor has been confirmed to have a homozygous MTAP deletion (a specific genetic change your oncologist can check for) - You have measurable cancer on imaging scans - Tumor tissue is available for testing - You are able to swallow oral medications - Your cancer type is one of those studied (e.g., non-small cell lung cancer, certain other solid tumors) **You may NOT be eligible if...** - Your tumor does not have the MTAP deletion - You have had certain prior treatments that disqualify you based on the specific study arm - You have uncontrolled health conditions that would make participation unsafe 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.

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Interventions

DRUGAnvumetostat

Administered PO

DRUGCarboplatin

Administered IV

DRUGPaclitaxel

Administered IV

DRUGPembrolizumab

Administered IV

DRUGPemetrexed

Administered IV

DRUGSotorasib

Administered PO

Locations(83)

Comprehensive Blood and Cancer Center

Bakersfield, California, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Duarte, California, United States

Translational Research in Oncology US Inc, Trio Central Pharmacy

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

University of California Los Angeles

Santa Monica, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

HealthPartners Institute

Saint Paul, Minnesota, United States

Saint Lukes Hospital of Kansas City

Kansas City, Missouri, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

New York University Grossman School of Medicine

New York, New York, United States

Perlmutter Cancer Center at New York University Langone Hospital----Long Island

New York, New York, United States

Upstate University Hospital

Syracuse, New York, United States

Hightower Clinical

Oklahoma City, Oklahoma, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Tennessee Medical Center Knoxville

Knoxville, Tennessee, United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States

Texas Oncology - Dallas Fort Worth

Dallas, Texas, United States

US Oncology Research Investigational Products Center

Dallas, Texas, United States

Oncology Consultants Cancer Center

Houston, Texas, United States

Texas Oncology Northeast Texas

Tyler, Texas, United States

Virginia Cancer Specialists PC

Fairfax, Virginia, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

Instituto Argentino de Diagnóstico y Tratamiento

Ciudad Automona de Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Cemic

Ciudad Autonoma Buenos Aires, Argentina

Orange Health Service

Orange, New South Wales, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Medizinische Universitaet Graz

Graz, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, Belgium

Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Cipo - Centro Integrado de Pesquisa em Oncologia

Porto Alegre, Rio Grande do Sul, Brazil

Fund Faculdade Regional Med Sao Jose Rio Preto

São José do Rio Preto, São Paulo, Brazil

Beneficencia Portuguesa de Sao Paulo - Bp

São Paulo, São Paulo, Brazil

Instituto Cancer Sao Paulo Icesp

São Paulo, Brazil

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, 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

Jilin Cancer Hospital

Changchun, Jilin, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

Beijing Cancer Hospital

Beijing, China

Institut Bergonie

Bordeaux, France

Hopital de la Timone

Marseille, France

Institut de Cancerologie de l Ouest Rene Gauducheau

Saint-Herblain, France

Gustave Roussy

Villejuif, France

Universitaetsklinikum Essen

Essen, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Alexandra Hospital

Athens, Greece

General Hospital Of Thessaloniki Papageorgiou

Thessaloniki, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

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

Fondazione IRCCS Istituto Nazionale dei Tumori

Alessandria, Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy

IRCCS Istituto Clinico Humanitas

Rozzano (MI), Italy

Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

Verona, Italy

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Gliwice, Poland

Futuremeds spolka z ograniczona odpowiedzialnoscia

Krakow, Poland

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

Centrum Medyczne Hope Clinic Sebastian Szklener

Lublin, Poland

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

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NCT06333951

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