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Advanced Gastrointestinal, Biliary Tract, and Pancreatic CancersPhase 1MTAPESTRY 103NCT06360354

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 1 study testing Anvumetostat, Gemcitabine and Nab-paclitaxel in people with Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers, run by Amgen at 77 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Anvumetostat, Gemcitabine and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
77 sitesin 16 countries
Study dates
29 May 2024to 30 Nov 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • Subprotocol C
  • 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.

Trial locations and contacts

77 sites in 16 countries.

77 sites in 16 countries

United States29 sites

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22903

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • City of Hope National Medical Center

    Duarte, California, 91010

  • City of Hope Orange County Lennar Foundation Cancer Center

    Duarte, California, 91010

  • Duke University

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Oncology Consultants Cancer Center

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • US Oncology Research Investigational Products Center

    Irving, Texas, 75063

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Translational Research in Oncology US Inc, Trio Central Pharmacy

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203

  • Yale University

    New Haven, Connecticut, 06520

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • University of Nebraska

    Omaha, Nebraska, 68198

  • University of California Los Angeles

    Santa Monica, California, 90404

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98106

  • Washington University

    St Louis, Missouri, 63110

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington, 98684

Other trials in United States

Australia6 sites

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, 3084

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Epworth Healthcare

    St Albans, Victoria, 3021

  • GenesisCare -North Shore Oncology

    St Leonards, New South Wales, 2065

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

China6 sites

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510030

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

France4 sites

  • Institut Bergonie

    Bordeaux, 33000

  • Centre Georges Francois Leclerc

    Dijon, 21000

  • Institut Paoli Calmettes

    Marseille, 13009

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy4 sites

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • IRCCS Istituto Clinico Humanitas

    Rozzano MI, 20089

  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

    Verona, 37134

Other trials in Italy

Japan4 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

Belgium3 sites

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Canada3 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • CHU de Quebec Hopital de l Enfant Jesus

    Québec, Quebec, G1J 1Z4

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Germany3 sites

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078

Other trials in Germany

Greece3 sites

  • Alexandra Hospital

    Athens, 11528

  • General Hospital Of Thessaloniki Papageorgiou

    Thessaloniki, 56429

  • European Interbalkan Medical Center

    Thessaloniki, 57001

Other trials in Greece

Spain3 sites

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

Other trials in Spain

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Hong Kong2 sites

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories

Other trials in Hong Kong

United Kingdom2 sites

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

Other trials in United Kingdom

Denmark1 site

  • Herlev og Gentofte Hospital

    Herlev, 2730

Other trials in Denmark

Netherlands1 site

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA

Other trials in Netherlands

About this study

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

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.

Being tested
Anvumetostat, Gemcitabine, Nab-paclitaxel, Modified FOLFIRINOX, RMC-6236
Keywords
Advanced Cancer, Methylthioadenosine Phosphorylase, AMG 193, Oncology
Medical subject headings
Pancreatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnvumetostatDrug

    Also called AMG 193

    Administered Orally

  • GemcitabineDrug

    Administered IV

  • Nab-paclitaxelDrug

    Administered IV

  • Modified FOLFIRINOXDrug

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

  • RMC-6236Drug

    Administered orally

Study groups in NCT06360354
Study groupRoleWhat they receive
Subprotocol B: Pancreatic Ductal Adenocarcinoma (PDAC) Arm AExperimentalPart 1: Participants with MTAP-deleted PDAC will receive doses of Anvumetostat orally in combination with gemcitabine and nab-paclitaxel IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of Anvumetostat in combination with gemcitabine and nab-paclitaxel.
Receives: Drug: Anvumetostat; Drug: Gemcitabine; Drug: Nab-paclitaxel
Subprotocol B: PDAC Arm BExperimentalPart 1: Participants with MTAP-deleted PDAC will receive doses of Anvumetostat orally in combination with mFOLFIRINOX (irinotecan, fluorouracil, leucovorin calcium, oxaliplatin) IV. Part 2: Participants with MTAP-deleted PDAC will receive the recommended dose of Anvumetostat in combination with mFOLFIRINOX.
Receives: Drug: Anvumetostat; Drug: Modified FOLFIRINOX
Subprotocol C: Dose ExplorationExperimentalPart 1: Participants with MTAP-deleted PDAC will receive oral doses of Anvumetostat and RMC-6236.
Receives: Drug: Anvumetostat; Drug: RMC-6236
Subprotocol C: Dose ExpansionExperimentalPart 2: Participants with MTAP-deleted PDAC will receive oral doses of Anvumetostat andRMC-6236.
Receives: Drug: Anvumetostat; Drug: RMC-6236

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Dose Limiting Toxicities (DLT)

    Measured: Up to 28 days

  2. Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)

    Any clinically significant changes in vital signs, electrocardiogram, or lab parameters will be recorded as TEAEs.

    Measured: Up to approximately 2 years

  3. Number of Participants Experiencing Serious Adverse Events (SAE)

    Measured: Up to approximately 2 years

Secondary outcomes (12)

  1. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: Up to approximately 2 years

  2. Disease Control (DC) per RECIST v1.1

    Measured: Up to approximately 2 years

  3. Duration of Response (DOR) per RECIST v1.1

    Measured: Up to approximately 2 years

  4. Time to Response (TTR) per RECIST v1.1

    Measured: Up to approximately 2 years

  5. Overall Survival (OS) per RECIST v1.1

    Measured: Up to approximately 2 years

  6. Progression-free Survival (PFS) per RECIST v1.1

    Measured: Up to approximately 2 years

  7. Maximum Plasma Concentration (Cmax) of Anvumetostat

    Measured: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)

  8. Time to Maximum Plasma Concentration (tmax) of Anvumetostat

    Measured: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)

  9. Area Under the Plasma Concentration-time Curve (AUC) of Anvumetostat

    Measured: Up to Day 1 of Cycle 5 (one cycle = 21 or 28 days)

  10. Cmax of RMC-6236

    Measured: Up to Day 1 of Cycle 5 (one cycle = 21 days)

  11. Tmax of RMC-6236

    Measured: Up to Day 1 of Cycle 5 (one cycle = 21 days)

  12. AUC of RMC-6236

    Measured: Up to Day 1 of Cycle 5 (one cycle = 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start29 May 2024
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06360354
Sponsor's protocol ID
20230223
Acronym
MTAPESTRY 103
Status last verified
May 2026
First submitted
8 Apr 2024
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anvumetostat, Gemcitabine and Nab-paclitaxel in people with Advanced Gastrointestinal, Biliary Tract, and Pancreatic Cancers, run by Amgen at 77 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Australia, China, France, Italy and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose Limiting Toxicities (DLT) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06360354.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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