RecruitingPhase 1NCT06360354

A Study Evaluating Anvumetostat in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103)

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Anvumetostat in Combination With Other Therapies in Subjects With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous MTAP-deletion

Sponsor

Amgen

Enrollment

350 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers

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 gastrointestinal, biliary tract, or pancreatic cancers. 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 gastrointestinal, biliary tract, or pancreatic cancers.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial (MTAPESTRY 103) is testing an experimental drug called AMG 193 in combination with other therapies for people with advanced pancreatic or other gastrointestinal/biliary cancers that carry a specific genetic deletion called MTAP. Cancers with this deletion may be especially vulnerable to AMG 193, which targets a metabolic pathway the cancer depends on. **You may be eligible if...** - You are 18 or older - You have been confirmed by biopsy to have metastatic or unresectable advanced pancreatic cancer, biliary tract cancer, or other GI cancer - Your tumor has a homozygous MTAP deletion (a specific genetic alteration confirmed by testing) - You have measurable disease - You have adequate organ function - Tumor tissue is available for testing **You may NOT be eligible if...** - You have previously received a MAT2A inhibitor or PRMT5 inhibitor - You had radiation therapy within 28 days of starting treatment - You had major surgery within 28 days of starting treatment - You have a history of solid organ transplant - You have serious GI problems that prevent taking oral medication 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 Orally

DRUGGemcitabine

Administered IV

DRUGNab-paclitaxel

Administered IV

DRUGModified FOLFIRINOX

Modified FOLFIRINOX consists of irinotecan, 5-FU, LV, and oxaliplatin administered IV

DRUGRMC-6236

Administered orally

Locations(77)

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

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Translational Research in Oncology US Inc, Trio Central Pharmacy

Los Angeles, California, United States

University of California Los Angeles

Santa Monica, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

University of Nebraska

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States

Oncology Consultants Cancer Center

Houston, Texas, United States

US Oncology Research Investigational Products Center

Irving, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Virginia Cancer Specialists PC

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

Northwest Cancer Specialists - Vancouver

Vancouver, Washington, United States

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia

GenesisCare -North Shore Oncology

St Leonards, New South Wales, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Austin Health, Austin Hospital

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Epworth Healthcare

St Albans, Victoria, Australia

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

CHU de Quebec Hopital de l Enfant Jesus

Québec, Quebec, Canada

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 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 First Bethune Hospital of Jilin University

Changchun, Jilin, China

Herlev og Gentofte Hospital

Herlev, Denmark

Institut Bergonie

Bordeaux, France

Centre Georges Francois Leclerc

Dijon, France

Institut Paoli Calmettes

Marseille, 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

Milan, 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

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Sarah Cannon Research Institute UK

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06360354