Actively Recruiting

Phase 1
Age: 18Years - 100Years
All Genders
NCT06360354

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)

Led by Amgen · Updated on 2026-03-31

350

Participants Needed

77

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older (or legal adult age in country if higher)
  • Histologically or cytologically confirmed metastatic and/or unresectable (locally advanced) pancreatic adenocarcinoma
  • Available tumor tissue sample or willingness to undergo tumor biopsy before dosing
  • Confirmed homozygous MTAP-deletion
  • Measurable disease as defined by RECIST v1.1
  • Adequate organ function as defined in the study protocol
  • For Subprotocol C: presence of RAS mutation and at least one prior systemic therapy for advanced or metastatic pancreatic ductal adenocarcinoma
Not Eligible

You will not qualify if you...

  • Prior treatment with MAT2A inhibitors, PRMT5 inhibitors, or MAPK pathway inhibitors including KRAS inhibitors (for Subprotocol C)
  • Radiation therapy within 28 days before first dose
  • Major surgery within 28 days before first dose of Anvumetostat
  • Cardiovascular and pulmonary conditions as defined in the protocol
  • Gastrointestinal tract disorders causing inability to take oral medication, malabsorption syndrome, need for IV alimentation, gastric/jejunal tube feeding, or uncontrolled inflammatory gastrointestinal diseases such as Crohn's disease or ulcerative colitis
  • History of solid organ transplantation

AI-Screening

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Trial Site Locations

Total: 77 locations

1

Comprehensive Blood and Cancer Center

Bakersfield, California, United States, 93309

Actively Recruiting

2

City of Hope National Medical Center

Duarte, California, United States, 91010

Actively Recruiting

3

City of Hope Orange County Lennar Foundation Cancer Center

Duarte, California, United States, 91010

Actively Recruiting

4

University of California San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Actively Recruiting

5

Translational Research in Oncology US Inc, Trio Central Pharmacy

Los Angeles, California, United States, 90095

Actively Recruiting

6

University of California Los Angeles

Santa Monica, California, United States, 90404

Actively Recruiting

7

Rocky Mountain Cancer Centers

Aurora, Colorado, United States, 80012

Actively Recruiting

8

Hartford Hospital

Hartford, Connecticut, United States, 06106

Actively Recruiting

9

Yale University

New Haven, Connecticut, United States, 06520

Actively Recruiting

10

Norwalk Hospital

Norwalk, Connecticut, United States, 06856

Actively Recruiting

11

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

12

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

13

Norton Cancer Institute

Louisville, Kentucky, United States, 40202

Actively Recruiting

14

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

15

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

16

Washington University

St Louis, Missouri, United States, 63110

Actively Recruiting

17

University of Nebraska

Omaha, Nebraska, United States, 68198

Actively Recruiting

18

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

Terminated

19

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

20

Duke University

Durham, North Carolina, United States, 27710

Actively Recruiting

21

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

22

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States, 37203

Actively Recruiting

23

Oncology Consultants Cancer Center

Houston, Texas, United States, 77030

Terminated

24

US Oncology Research Investigational Products Center

Irving, Texas, United States, 75063

Actively Recruiting

25

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22903

Actively Recruiting

26

Virginia Cancer Specialists PC

Fairfax, Virginia, United States, 22031

Actively Recruiting

27

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98106

Actively Recruiting

28

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States, 98405

Actively Recruiting

29

Northwest Cancer Specialists - Vancouver

Vancouver, Washington, United States, 98684

Completed

30

Chris OBrien Lifehouse

Camperdown, New South Wales, Australia, 2050

Actively Recruiting

31

GenesisCare -North Shore Oncology

St Leonards, New South Wales, Australia, 2065

Actively Recruiting

32

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia, 5011

Actively Recruiting

33

Austin Health, Austin Hospital

Heidelberg, Victoria, Australia, 3084

Actively Recruiting

34

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Actively Recruiting

35

Epworth Healthcare

St Albans, Victoria, Australia, 3021

Actively Recruiting

36

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium, 1200

Actively Recruiting

37

Universitair Ziekenhuis Antwerpen

Edegem, Belgium, 2650

Actively Recruiting

38

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium, 3000

Actively Recruiting

39

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

40

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 1Z5

Actively Recruiting

41

CHU de Quebec Hopital de l Enfant Jesus

Québec, Quebec, Canada, G1J 1Z4

Actively Recruiting

42

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350028

Actively Recruiting

43

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China, 510030

Actively Recruiting

44

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150000

Actively Recruiting

45

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

46

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022

Actively Recruiting

47

The First Bethune Hospital of Jilin University

Changchun, Jilin, China, 130021

Actively Recruiting

48

Herlev og Gentofte Hospital

Herlev, Denmark, 2730

Actively Recruiting

49

Institut Bergonie

Bordeaux, France, 33000

Actively Recruiting

50

Centre Georges Francois Leclerc

Dijon, France, 21000

Actively Recruiting

51

Institut Paoli Calmettes

Marseille, France, 13009

Actively Recruiting

52

Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

53

Universitaetsklinikum Essen

Essen, Germany, 45147

Actively Recruiting

54

Universitaetsklinikum Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

55

Universitaetsklinikum Wuerzburg

Würzburg, Germany, 97078

Actively Recruiting

56

Alexandra Hospital

Athens, Greece, 11528

Actively Recruiting

57

General Hospital Of Thessaloniki Papageorgiou

Thessaloniki, Greece, 56429

Actively Recruiting

58

European Interbalkan Medical Center

Thessaloniki, Greece, 57001

Actively Recruiting

59

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

60

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Actively Recruiting

61

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy, 20133

Actively Recruiting

62

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Actively Recruiting

63

IRCCS Istituto Clinico Humanitas

Rozzano MI, Italy, 20089

Actively Recruiting

64

Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

Verona, Italy, 37134

Actively Recruiting

65

Aichi Cancer Center

Nagoya, Aichi-ken, Japan, 464-8681

Actively Recruiting

66

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan, 277-8577

Actively Recruiting

67

Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

Yokohama, Kanagawa, Japan, 241-8515

Actively Recruiting

68

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan, 104-0045

Actively Recruiting

69

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands, 6525 GA

Actively Recruiting

70

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain, 41013

Actively Recruiting

71

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain, 08035

Actively Recruiting

72

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28009

Actively Recruiting

73

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Actively Recruiting

74

National Taiwan University Hospital

Taipei, Taiwan, 10002

Actively Recruiting

75

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Actively Recruiting

76

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom, B15 2TH

Actively Recruiting

77

Sarah Cannon Research Institute UK

London, United Kingdom, W1G 6AD

Actively Recruiting

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Research Team

A

Amgen Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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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) | DecenTrialz