A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)
NCT ID: NCT06593522
Last Updated: 2025-12-12
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
PHASE2
200 participants
INTERVENTIONAL
2024-12-26
2030-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose Evaluation
Participants will be randomized to receive one of 2 active dose levels of AMG 193 orally (PO) daily (QD) in 28 days cycles. Part 1 of the study will determine the recommended phase 2 dose (RP2D).
AMG 193
Film-coated tablet
Part 2: Dose Expansion
Participants will receive AMG 193 PO QD in 28-day cycles at the RP2D.
AMG 193
Film-coated tablet
Interventions
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AMG 193
Film-coated tablet
Eligibility Criteria
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Inclusion Criteria
* Participants will have received and progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.
* Either an archival tissue sample or an archival block must be available.
* Life expectancy of greater than 3 months, in the opinion of the investigator.
* Participants who have had brain metastases and have been appropriately treated with radiation therapy or surgery ending at least 14 days before study day 1 are eligible.
* Participants with untreated asymptomatic brain metastases smaller or equal to 2 cm in size (per lesion if more than one) and not requiring corticosteroid treatment are eligible.
Exclusion Criteria
• Tumors harboring the following mutations amenable to targeted therapies: epidermal growth factor receptor (EGFR), ALK receptor tyrosine kinase (ALK), ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), MET proto-oncogene (MET), B-Raf proto-oncogene (BRAF), RET proto-oncogene (RET), Human epidermal growth factor receptor 2 (HER2/ERBB2), KRAS proto-oncogene G12C (KRAS G12C).
Other Medical Conditions
* Major surgery within 28 days of study day 1.
* Untreated symptomatic central nervous system (CNS) metastatic disease regardless of size or asymptomatic brain metastases greater than 2 cm per lesion.
18 Years
99 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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City of Hope National Medical Center
Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Hartford HealthCare Cancer Institute - Manchester
Plainville, Connecticut, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Our Lady of the Lake Cancer Institute
Baton Rouge, Louisiana, United States
Trinity Health Saint Joseph Mercy Ann Arbor
Ann Arbor, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, United States
Texas Oncology Central/South Texas
Austin, Texas, United States
Sarah Cannon Research Institute
Dallas, Texas, United States
Texas Oncology - Dallas Fort Worth
Dallas, Texas, United States
US Oncology Research Investigational Products Center
Irving, Texas, United States
Texas Oncology Northeast Texas
Tyler, Texas, United States
Virginia Cancer Specialists PC
Fairfax, Virginia, United States
GenesisCare -North Shore Oncology
St Leonards, New South Wales, Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
Mater Hospital Brisbane
South Brisbane, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Núcleo de Oncologia da Bahia
Salvador, Estado de Bahia, Brazil
Liga Norte-Riograndense Contra O Cancer
Natal, Rio Grande do Norte, Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio Xii Barretos
Barretos, São Paulo, Brazil
Fund Fac Reg Med Sao Jose Rio Preto
São José do Rio Preto, São Paulo, Brazil
Instituto do Cancer Estado SP Icesp
São Paulo, São Paulo, Brazil
Fundacao Antonio Prudente - Hosp AC Camargo
São Paulo, São Paulo, Brazil
Instituto de Educacao Pesquisa e Gestao em Saude
Rio de Janeiro, , Brazil
Centro Paulista de Oncologia
São Paulo, , Brazil
Cross Cancer Institute
Edmonton, Alberta, Canada
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre Glen Site
Montreal, Quebec, Canada
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Henan Cancer Hospital
Zhengzhou, Henan, 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
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jilin Cancer Hospital
Changchun, Jilin, China
Jinan Central Hospital
Jinan, Shandong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, , China
Beijing Chest Hospital, Capital Medical University
Beijing, , China
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni Thomayerova nemocnice
Prague, , Czechia
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
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Riga East Clinical University Hospital
Riga, , Latvia
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
Sint Jansdal Ziekenhuis
Harderwijk, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Unidade Local de Saude de Braga, EPE
Braga, , Portugal
Fundacao Champalimaud
Lisbon, , Portugal
Hospital Cuf porto
Porto, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, , Portugal
National University Hospital
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Cha Bundang Medical Center, Cha University
Seongnam-si, Gyeonggi-do, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Ajou University Hospital
Suwon-si Gyeonggi-do, , South Korea
The Catholic University of Korea St Vincents Hospital
Suwon-si, Gyeonggi-do, , South Korea
Universitaetsspital Basel
Basel, , Switzerland
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, , Switzerland
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, , Turkey (Türkiye)
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Memorial Bahcelievler Hastanesi
Istanbul, , Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, , 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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20230153
Identifier Type: -
Identifier Source: org_study_id
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