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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)
Sponsor: Amgen
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-05-29
Completion Date
2029-02-25
Last Updated
2026-03-31
Healthy Volunteers
No
Interventions
Anvumetostat
Administered Orally
Gemcitabine
Administered IV
Nab-paclitaxel
Administered IV
Modified FOLFIRINOX
Modified FOLFIRINOX consists of irinotecan, 5-FU, LV, and oxaliplatin administered IV
RMC-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