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New combo therapy targets Hard-to-Treat cancers with genetic marker

NCT ID NCT06360354

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new drug called anvumetostat, given together with other standard chemotherapy drugs, for people with advanced cancers of the digestive system (stomach, bile ducts, or pancreas) that have a specific genetic change called MTAP deletion. The main goals are to find the safest dose and to check for side effects. About 120 adults will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anvumetostat (AMG 193) combined with gemcitabine, nab-paclitaxel, modified FOLFIRINOX, or RMC-6236
What this could lead to
If successful, this could point toward a new treatment option for people with certain hard-to-treat digestive cancers that have a specific genetic marker.
What could go wrong
This is an early Phase 1b trial with only 120 participants, so it is primarily testing safety and dosing. It is too soon to know if the combination will work, and there may be side effects from the drugs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

120 people

The number who actually took part.

Started

May 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm pancreatic adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced gastrointestinal, biliary tract, and pancreatic cancers

Contacts and locations

Locations

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • Alexandra Hospital

    Athens, 11528, Greece

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHU de Quebec Hopital de l Enfant Jesus

    Québec, Quebec, G1J 1Z4, Canada

  • Centre Georges Francois Leclerc

    Dijon, 21000, France

  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

    Verona, 37134, Italy

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • City of Hope Orange County Lennar Foundation Cancer Center

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Epworth Healthcare

    St Albans, Victoria, 3021, Australia

  • European Interbalkan Medical Center

    Thessaloniki, 57001, Greece

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98106, United States

  • General Hospital Of Thessaloniki Papageorgiou

    Thessaloniki, 56429, Greece

  • GenesisCare -North Shore Oncology

    St Leonards, New South Wales, 2065, Australia

  • Gustave Roussy

    Villejuif, 94805, France

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • Herlev og Gentofte Hospital

    Herlev, 2730, Denmark

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013, Spain

  • IRCCS Istituto Clinico Humanitas

    Rozzano MI, 20089, Italy

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Institut Bergonie

    Bordeaux, 33000, France

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, 350028, China

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington, 98684, United States

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40202, United States

  • Norwalk Hospital

    Norwalk, Connecticut, 06856, United States

  • Oncology Consultants Cancer Center

    Houston, Texas, 77030, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories, Hong Kong

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1Z5, Canada

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH, United Kingdom

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong, Hong Kong

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA, Netherlands

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012, United States

  • Sarah Cannon Research Institute UK

    London, W1G 6AD, United Kingdom

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510030, China

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011, Australia

  • Translational Research in Oncology US Inc, Trio Central Pharmacy

    Los Angeles, California, 90095, United States

  • US Oncology Research Investigational Products Center

    Irving, Texas, 75063, United States

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

    Wuhan, Hubei, 430022, China

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203, United States

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97078, Germany

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • University of California Los Angeles

    Santa Monica, California, 90404, United States

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Nebraska

    Omaha, Nebraska, 68198, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22903, United States

  • Virginia Cancer Specialists PC

    Fairfax, Virginia, 22031, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.