Actively Recruiting

Phase 1
Age: 18Years - 100Years
All Genders
NCT06333951

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

Led by Amgen · Updated on 2026-04-13

500

Participants Needed

83

Research Sites

370 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 thoracic tumors. 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 thoracic tumors.

CONDITIONS

Official Title

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).

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 if higher in country)
  • Available tumor tissue sample or willingness to undergo biopsy before treatment
  • Confirmed homozygous MTAP deletion in tumor
  • Able to swallow and retain oral study medication
  • Disease measurable by RECIST v1.1 criteria
  • For Subprotocol A: confirmed diagnosis of non-small cell lung cancer (NSCLC)
  • For Arm A: predominantly squamous cell histology
  • For Arm B: predominantly non-squamous cell histology
  • For Arm C: PD-L1 positive tumors
  • For Subprotocol B: NSCLC with homozygous MTAP deletion and KRAS p.G12C mutation
  • For Subprotocol C: NSCLC with brain metastases meeting measurable disease criteria
Not Eligible

You will not qualify if you...

  • Cardiovascular and pulmonary conditions as detailed in the protocol
  • Gastrointestinal diseases causing inability to take oral medication or malabsorption
  • History of solid organ transplant
  • Major surgery within 28 days before first dose
  • Prior treatment with MAT2A or PRMT5 inhibitors
  • Radiation therapy within 28 days before first dose
  • For Subprotocol A: autoimmune or immunodeficiency diseases as defined in the protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 83 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

Terminated

3

City of Hope Orange County Lennar Foundation Cancer Center

Duarte, California, United States, 91010

Terminated

4

Translational Research in Oncology US Inc, Trio Central Pharmacy

Los Angeles, California, United States, 90095

Actively Recruiting

5

University of California Irvine

Orange, California, United States, 92868-3217

Actively Recruiting

6

University of California Los Angeles

Santa Monica, California, United States, 90404

Actively Recruiting

7

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80218

Actively Recruiting

8

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States, 06360

Terminated

9

HealthPartners Institute

Saint Paul, Minnesota, United States, 55102

Actively Recruiting

10

Saint Lukes Hospital of Kansas City

Kansas City, Missouri, United States, 64111

Terminated

11

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

Terminated

12

Roswell Park Cancer Institute

Buffalo, New York, United States, 32224

Actively Recruiting

13

New York University Grossman School of Medicine

New York, New York, United States, 10016

Actively Recruiting

14

Perlmutter Cancer Center at New York University Langone Hospital----Long Island

New York, New York, United States, 10016

Actively Recruiting

15

Upstate University Hospital

Syracuse, New York, United States, 13210

Actively Recruiting

16

Hightower Clinical

Oklahoma City, Oklahoma, United States, 73102

Actively Recruiting

17

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

18

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

19

University of Tennessee Medical Center Knoxville

Knoxville, Tennessee, United States, 37920

Actively Recruiting

20

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, United States, 37203

Actively Recruiting

21

Texas Oncology - Dallas Fort Worth

Dallas, Texas, United States, 75246

Terminated

22

US Oncology Research Investigational Products Center

Dallas, Texas, United States, 75246

Actively Recruiting

23

Oncology Consultants Cancer Center

Houston, Texas, United States, 77030

Terminated

24

Texas Oncology Northeast Texas

Tyler, Texas, United States, 75702

Actively Recruiting

25

Virginia Cancer Specialists PC

Fairfax, Virginia, United States, 22031

Actively Recruiting

26

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States, 98405

Actively Recruiting

27

Instituto Argentino de Diagnóstico y Tratamiento

Ciudad Automona de Buenos Aires, Buenos Aires, Argentina, C1117ABC

Actively Recruiting

28

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina, B1629ODT

Actively Recruiting

29

Cemic

Ciudad Autonoma Buenos Aires, Argentina, C1431FWO

Actively Recruiting

30

Orange Health Service

Orange, New South Wales, Australia, 2800

Actively Recruiting

31

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia, 5011

Actively Recruiting

32

Medizinische Universitaet Graz

Graz, Austria, 8036

Actively Recruiting

33

Medizinische Universitaet Innsbruck

Innsbruck, Austria, 6020

Actively Recruiting

34

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, Belgium, 4000

Actively Recruiting

35

Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil, 98700-000

Actively Recruiting

36

Cipo - Centro Integrado de Pesquisa em Oncologia

Porto Alegre, Rio Grande do Sul, Brazil, 91350-200

Actively Recruiting

37

Fund Faculdade Regional Med Sao Jose Rio Preto

São José do Rio Preto, São Paulo, Brazil, 15090-000

Actively Recruiting

38

Beneficencia Portuguesa de Sao Paulo - Bp

São Paulo, São Paulo, Brazil, 01509-900

Actively Recruiting

39

Instituto Cancer Sao Paulo Icesp

São Paulo, Brazil, 01246-000

Actively Recruiting

40

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

41

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350028

Actively Recruiting

42

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China, 510000

Actively Recruiting

43

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

44

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022

Actively Recruiting

45

Jilin Cancer Hospital

Changchun, Jilin, China, 130012

Actively Recruiting

46

West China Hospital Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

47

Beijing Cancer Hospital

Beijing, China, 100142

Actively Recruiting

48

Institut Bergonie

Bordeaux, France, 33000

Actively Recruiting

49

Hopital de la Timone

Marseille, France, 13005

Actively Recruiting

50

Institut de Cancerologie de l Ouest Rene Gauducheau

Saint-Herblain, France, 44805

Actively Recruiting

51

Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

52

Universitaetsklinikum Essen

Essen, Germany, 45147

Actively Recruiting

53

Universitaetsklinikum Heidelberg

Heidelberg, Germany, 69126

Actively Recruiting

54

Universitaetsklinikum Wuerzburg

Würzburg, Germany, 97078

Actively Recruiting

55

Alexandra Hospital

Athens, Greece, 11528

Actively Recruiting

56

General Hospital Of Thessaloniki Papageorgiou

Thessaloniki, Greece, 56429

Actively Recruiting

57

European Interbalkan Medical Center

Thessaloniki, Greece, 57001

Actively Recruiting

58

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

59

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Actively Recruiting

60

Fondazione IRCCS Istituto Nazionale dei Tumori

Alessandria, Italy, 15100

Actively Recruiting

61

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Actively Recruiting

62

IRCCS Istituto Clinico Humanitas

Rozzano (MI), Italy, 20089

Actively Recruiting

63

Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

Verona, Italy, 37126

Actively Recruiting

64

Aichi Cancer Center

Nagoya, Aichi-ken, Japan, 464-8681

Actively Recruiting

65

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan, 277-8577

Actively Recruiting

66

Shizuoka Cancer Center

Sunto-gun, Shizuoka, Japan, 411-8777

Actively Recruiting

67

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan, 641-8510

Actively Recruiting

68

Radboud Universitair Medisch Centrum

Nijmegen, Netherlands, 6525 GA

Actively Recruiting

69

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland, 80-214

Actively Recruiting

70

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Gliwice, Poland, 44-102

Actively Recruiting

71

Futuremeds spolka z ograniczona odpowiedzialnoscia

Krakow, Poland, 31-501

Actively Recruiting

72

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland, 93-338

Actively Recruiting

73

Centrum Medyczne Hope Clinic Sebastian Szklener

Lublin, Poland, 20-701

Actively Recruiting

74

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

75

Asan Medical Center

Seoul, South Korea, 05505

Actively Recruiting

76

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain, 08035

Actively Recruiting

77

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, Spain, 08036

Actively Recruiting

78

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

79

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Actively Recruiting

80

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Actively Recruiting

81

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, Turkey (Türkiye), 01370

Actively Recruiting

82

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye), 06230

Actively Recruiting

83

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye), 06800

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

5

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Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104). | DecenTrialz