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NCT06360354Active, not recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
120 (actual)
First submitted
8 Apr 2024
Start date
May 2024
Primary completion date
Oct 2026
Lead sponsor
Amgen
NCT number
NCT06360354

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 120
  • From May 2024 to the primary completion date, Oct 2026
  • 77 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Subprotocol B
  • 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.
  • 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 Anvumetostat.
  • Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
  • 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.
    • 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.
  • Cardiovascular and pulmonary exclusion criteria as defined in the protocol.
  • 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.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (77)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chris Obrien Lifehouse
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CamperdownAustraliaUnknown status
Austin Health, Austin Hospital
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HeidelbergAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
Epworth Healthcare
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St AlbansAustraliaUnknown status
GenesisCare -North Shore Oncology
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St LeonardsAustraliaUnknown status
The Queen Elizabeth Hospital
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Woodville SouthAustraliaUnknown status
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
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BrusselsBelgiumUnknown status
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumUnknown status
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
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LeuvenBelgiumUnknown status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
CHU de Quebec - Hôpital de l' Enfant Jésus
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QuébecCanadaUnknown status
Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
The First Bethune Hospital of Jilin University
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ChangchunChinaUnknown status
Mengchao Hepatobiliary Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Sun Yat-sen University Cancer Center
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GuangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Universitaetsklinikum - Essen
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EssenGermanyUnknown status
Universitaetsklinikum Heidelberg
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HeidelbergGermanyUnknown status
Universitaetsklinikum Wuerzburg
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WürzburgGermanyUnknown status
Herlev og Gentofte Hospital
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HerlevDenmarkUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital General Universitario Gregorio Marañón
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MadridSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
Institut Bergonie
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BordeauxFranceUnknown status
Centre Georges François Leclerc
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DijonFranceUnknown status
Institut Paoli-Calmettes
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MarseilleFranceUnknown status
Gustave Roussy
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VillejuifFranceUnknown status
Queen Elizabeth Hospital Birmingham
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BirminghamUnited KingdomUnknown status
Sarah Cannon Research Institute UK
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LondonUnited KingdomUnknown status
Alexandra Hospital
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AthensGreeceUnknown status
General Hospital of Thessaloniki Papageorgiou
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ThessalonikiGreeceUnknown status
European Interbalkan Medical Center
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ThessalonikiGreeceUnknown status
Queen Mary Hospital, The University of Hong Kong
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hospital, Chinese University of Hong Kong
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Shatin, New TerritoriesHong Kong SAR ChinaUnknown status
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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MilanItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyUnknown status
IRCCS Istituto Clinico Humanitas
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Rozzano MIItalyUnknown status
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
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VeronaItalyUnknown status
National Cancer Center Hospital
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Chuo KuJapanUnknown status
National Cancer Center Hospital East
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Kashiwa-shiJapanUnknown status
Aichi Cancer Center
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NagoyaJapanUnknown status
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
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YokohamaJapanUnknown status
Radboud Universitair Medisch Centrum
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NijmegenNetherlandsUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Rocky Mountain Cancer Centers
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AuroraUnited StatesUnknown status
Comprehensive Blood and Cancer Center
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BakersfieldUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
University of Virginia Cancer Center
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CharlottesvilleUnited StatesUnknown status
University of Chicago
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ChicagoUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
City of Hope Orange County Lennar Foundation Cancer Center
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DuarteUnited StatesUnknown status
City of Hope National Medical Center
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DuarteUnited StatesUnknown status
Duke University
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DurhamUnited StatesUnknown status
Virginia Cancer Specialists PC
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FairfaxUnited StatesUnknown status
Hartford Hospital
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HartfordUnited StatesUnknown status
Oncology Consultants Cancer Center
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HoustonUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
US Oncology Research Investigational Products Center
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IrvingUnited StatesUnknown status
University of California San Diego Moores Cancer Center
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La JollaUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesUnknown status
Translational Research in Oncology US Inc, Trio Central Pharmacy
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Los AngelesUnited StatesUnknown status
Norton Cancer Institute
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LouisvilleUnited StatesUnknown status
United States Oncology Regulatory Affairs Corporate Office
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NashvilleUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Norwalk Hospital
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NorwalkUnited StatesUnknown status
University of Nebraska
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OmahaUnited StatesUnknown status
University of California, Los Angeles
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Santa MonicaUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Northwest Medical Specialties PLLC
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TacomaUnited StatesUnknown status
Northwest Cancer Specialists - Vancouver
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VancouverUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.