AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
NCT ID: NCT06333951
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
500 participants
INTERVENTIONAL
2024-09-17
2031-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A
Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV)
AMG 193
Administered PO
Carboplatin
Administered IV
Paclitaxel
Administered IV
Pembrolizumab
Administered IV
Subprotocol A: NSCLC Arm B
Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV
AMG 193
Administered PO
Carboplatin
Administered IV
Pembrolizumab
Administered IV
Pemetrexed
Administered IV
Subprotocol A: NSCLC Arm C
Participants with MTAP-deleted NSCLC will receive a combination of AMG 193 PO and pembrolizumab IV
AMG 193
Administered PO
Pembrolizumab
Administered IV
Subprotocol B: NSCLC With KRasG12C Mutation
Participants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of AMG 193 and sotorasib PO
AMG 193
Administered PO
Sotorasib
Administered PO
Subprotocol C: NSCLC With Brain Metastases
Participants with MTAP-deleted NSCLC with brain metastases will receive AMG 193 PO
AMG 193
Administered PO
Interventions
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AMG 193
Administered PO
Carboplatin
Administered IV
Paclitaxel
Administered IV
Pembrolizumab
Administered IV
Pemetrexed
Administered IV
Sotorasib
Administered PO
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
* Tumor tissue (formalin-fixed, paraffin-embedded sample) or an archival block must be available. Participants without archived tumor tissue available may be allowed to enroll by undergoing tumor biopsy before AMG 193 dosing.
* Homozygous MTAP-deletion
* Able to swallow and retain PO administered study treatment.
* Disease measurable as defined by RECIST v1.1.
Subprotocol A - Histologically or cytologically confirmed diagnosis of NSCLC.
Arm A (AMG 193 + carboplatin + paclitaxel + pembrolizumab):
\- Predominantly squamous histology.
Arm B (AMG 193 + carboplatin + pemetrexed + pembrolizumab):
\- Predominantly non-squamous histology.
Arm C (AMG 193 + pembrolizumab):
\- PD-L1 positive.
Subprotocol B - Histologically confirmed NSCLC with homozygous MTAP-deletion and KRAS p.G12C mutation.
Subprotocol C
* Histologically or cytologically confirmed diagnosis of NSCLC with brain metastases.
* Brain lesion meeting RANO-BM criteria for measurable disease.
Exclusion Criteria
* 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 transplant.
* Major surgery within 28 days of first dose of AMG 193.
* Prior treatment with a MAT2A inhibitor or a PRMT5 inhibitor.
* Radiation therapy within 28 days of first dose.
Subprotocol A
\- Autoimmune disease or immunodeficiency disease as defined in the protocol'
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Comprehensive Blood and Cancer Center
Bakersfield, California, United States
City of Hope National Medical Center
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, United States
Translational Research in Oncology US Inc, Trio Central Pharmacy
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
University of California Los Angeles
Santa Monica, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
HealthPartners Institute
Saint Paul, Minnesota, United States
Saint Lukes Hospital of Kansas City
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York University Grossman School of Medicine
New York, New York, United States
Perlmutter Cancer Center at New York University Langone Hospital----Long Island
New York, New York, United States
Upstate University Hospital
Syracuse, New York, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center Knoxville
Knoxville, Tennessee, United States
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, United States
Texas Oncology - Dallas Fort Worth
Dallas, Texas, United States
US Oncology Research Investigational Products Center
Dallas, Texas, United States
Oncology Consultants Cancer Center
Houston, Texas, United States
Texas Oncology Northeast Texas
Tyler, Texas, United States
Virginia Cancer Specialists PC
Fairfax, Virginia, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
Instituto Argentino de Diagnóstico y Tratamiento
Ciudad Automona de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Cemic
Ciudad Autonoma Buenos Aires, , Argentina
Orange Health Service
Orange, New South Wales, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Medizinische Universitaet Graz
Graz, , Austria
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Oncosite Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Cipo - Centro Integrado de Pesquisa em Oncologia
Porto Alegre, Rio Grande do Sul, Brazil
Fund Faculdade Regional Med Sao Jose Rio Preto
São José do Rio Preto, São Paulo, Brazil
Beneficencia Portuguesa de Sao Paulo - Bp
São Paulo, São Paulo, Brazil
Instituto Cancer Sao Paulo Icesp
São Paulo, , Brazil
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Jilin Cancer Hospital
Changchun, Jilin, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Beijing Cancer Hospital
Beijing, , China
Institut Bergonie
Bordeaux, , France
Hopital de la Timone
Marseille, , France
Institut de Cancerologie de l Ouest Rene Gauducheau
Saint-Herblain, , France
Gustave Roussy
Villejuif, , France
Universitaetsklinikum Essen
Essen, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Wuerzburg
Würzburg, , Germany
Alexandra Hospital
Athens, , Greece
Saint Luke Hospital
Thessaloniki, , Greece
General Hospital Of Thessaloniki Papageorgiou
Thessaloniki, , Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, , Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, , Hong Kong
Fondazione IRCCS Istituto Nazionale dei Tumori
Alessandria, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano (MI), , Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, , Italy
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Radboud Universitair Medisch Centrum
Nijmegen, , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Gliwice, , Poland
Futuremeds spolka z ograniczona odpowiedzialnoscia
Krakow, , Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, , Poland
Centrum Medyczne Hope Clinic Sebastian Szklener
Lublin, , Poland
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
National Cheng Kung University Hospital
Tainan, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20230167
Identifier Type: -
Identifier Source: org_study_id
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