A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103)
NCT ID: NCT06360354
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
350 participants
INTERVENTIONAL
2024-05-29
2029-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subprotocol C: Dose Exploration
Part 1: Participants with MTAP-deleted PDAC will receive oral doses of AMG 193 and RMC-6236.
AMG 193
Administered Orally
RMC-6236
Administered orally
Subprotocol C: Dose Expansion
Part 2: Participants with MTAP-deleted PDAC will receive oral doses of AMG 193 andRMC-6236.
AMG 193
Administered Orally
RMC-6236
Administered orally
Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm A
Part 1: Participants with MTAP-deleted PDAC will receive doses of AMG 193 orally in combination with gemcitabine and nab-paclitaxel IV.
Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with gemcitabine and nab-paclitaxel.
AMG 193
Administered Orally
Gemcitabine
Administered IV
Nab-paclitaxel
Administered IV
Subprotocol B: PDAC Arm B
Part 1: Participants with MTAP-deleted PDAC will receive doses of AMG 193 orally in combination with mFOLFIRINOX (irinotecan, fluorouracil, leucovorin calcium, oxaliplatin) IV.
Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of AMG 193 in combination with mFOLFIRINOX.
AMG 193
Administered Orally
Modified FOLFIRINOX
Modified FOLFIRINOX consists of irinotecan, 5-FU, LV, and oxaliplatin administered IV
Interventions
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AMG 193
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
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
* Tumor tissue (FFPE sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before dosing.
* Homozygous MTAP-deletion.
* Disease measurable as defined by RECIST v1.1.
* Adequate organ function as defined in the protocol.
Exclusion:
* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
* Radiation therapy within 28 days of first dose.
* Major surgery within 28 days of first dose of AMG 193.
Exclusion Criteria
* History of solid organ transplantation.
Subprotocol C
Inclusion:
* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
* Histologically or cytologically confirmed diagnosis of metastatic and/or unresectable (locally advanced) adenocarcinoma of the pancreas.
* Homozygous MTAP-deletion.
* Rat Sarcoma Viral Oncogene Homolog (RAS) mutation
* Received at least 1 prior systemic therapy for advanced or metastatic PDAC.
* Disease measurable as defined by RECIST v1.1.
* Adequate organ function as defined in the protocol.
Exclusion:
* Prior treatment with aMAT2A inhibitor, a PRMT5 inhibitor, or a MAPK pathway inhibitor, including KRAS inhibitors.
* Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).
* History of solid organ transplantation.
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20230223
Identifier Type: -
Identifier Source: org_study_id
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