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
- Diseases
- Pancreatic cancer
- 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
Sites (77)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chris Obrien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Austin Health, Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Peter MacCallum Cancer Centre Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Epworth Healthcare Coordinator of this site? Confirm its status | St Albans | Australia | Unknown status |
| GenesisCare -North Shore Oncology Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville South | Australia | Unknown status |
| Universite Catholique de Louvain Cliniques Universitaires Saint Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Arthur J.E. Child Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| CHU de Quebec - Hôpital de l' Enfant Jésus Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Universitaetsklinikum - Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitaetsklinikum Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Universitaetsklinikum Wuerzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
| Herlev og Gentofte Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Queen Elizabeth Hospital Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Sarah Cannon Research Institute UK Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| General Hospital of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| European Interbalkan Medical Center Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Queen Mary Hospital, The University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Prince of Wales Hospital, Chinese University of Hong Kong Coordinator of this site? Confirm its status | Shatin, New Territories | Hong Kong SAR China | Unknown status |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCCS Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano MI | Italy | Unknown status |
| Centro Ricerche Cliniche Di Verona Societa responsabilita limitata Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Aichi Cancer Center Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Radboud Universitair Medisch Centrum Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Rocky Mountain Cancer Centers Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Comprehensive Blood and Cancer Center Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| City of Hope Orange County Lennar Foundation Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Virginia Cancer Specialists PC Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Oncology Consultants Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| US Oncology Research Investigational Products Center Coordinator of this site? Confirm its status | Irving | United States | Unknown status |
| University of California San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Translational Research in Oncology US Inc, Trio Central Pharmacy Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| United States Oncology Regulatory Affairs Corporate Office Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Norwalk Hospital Coordinator of this site? Confirm its status | Norwalk | United States | Unknown status |
| University of Nebraska Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Northwest Medical Specialties PLLC Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Northwest Cancer Specialists - Vancouver Coordinator of this site? Confirm its status | Vancouver | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.