A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)

Last updated: June 4, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

AMG 193

Clinical Study ID

NCT06593522
20230153
  • Ages 18-99
  • All Genders

Study Summary

The main objective of the study is to characterize safety and efficacy of 2 dose levels of AMG 193 by investigator, and to evaluate AMG 193 monotherapy efficacy by Blinded Independent Central Review (BICR).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic or unresectable locallyadvanced MTAP-deleted (Homozygous deletion of MTAP) NSCLC

  • Participants will have received and progressed or experienced disease recurrence onor after receiving at least 1 prior systemic therapy for locally advanced andunresectable 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 withradiation therapy or surgery ending at least 14 days before study day 1 areeligible.

  • Participants with untreated asymptomatic brain metastases smaller or equal to 2 cmin size (per lesion if more than one) and not requiring corticosteroid treatment areeligible.

Exclusion

Exclusion Criteria:

Disease Related

• 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 ofsize or asymptomatic brain metastases greater than 2 cm per lesion.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: AMG 193
Phase: 2
Study Start date:
December 26, 2024
Estimated Completion Date:
September 11, 2029

Connect with a study center

  • GenesisCare -North Shore Oncology

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Mater Hospital Brisbane

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Núcleo de Oncologia da Bahia

    Salvador, Bahia 40170-110
    Brazil

    Active - Recruiting

  • Liga Norte-Riograndense Contra O Cancer

    Natal, Rio Grande Do Norte 59062-000
    Brazil

    Active - Recruiting

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande Do Sul 91010-004
    Brazil

    Active - Recruiting

  • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

    Porto Alegre, Rio Grande Do Sul 90610-000
    Brazil

    Active - Recruiting

  • Fundacao Pio 12 Hospital de Amor de Barretos

    Barretos, São Paulo 14784-400
    Brazil

    Active - Recruiting

  • Fundacao Antonio Prudente - Hosp AC Camargo

    Sao Paulo, São Paulo 01509-900
    Brazil

    Active - Recruiting

  • Instituto do Cancer Estado SP Icesp

    Sao Paulo, São Paulo 01246-000
    Brazil

    Active - Recruiting

  • Fund Fac Reg Med Sao Jose Rio Preto

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

    Active - Recruiting

  • Instituto de Educacao Pesquisa e Gestao em Saude

    Rio de Janeiro, 22775-001
    Brazil

    Active - Recruiting

  • Centro Paulista de Oncologia

    São Paulo, 04538-132
    Brazil

    Active - Recruiting

  • McGill University Health Centre Glen Site

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

  • Mengchao Hepatobiliary hospital of Fujian Medical University

    Fuzhou, Fujian 350028
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

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

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin 130012
    China

    Active - Recruiting

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai 200123
    China

    Active - Recruiting

  • West China Hospital Of Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310005
    China

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Active - Recruiting

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101149
    China

    Active - Recruiting

  • Masarykuv onkologicky ustav

    Brno, 656 53
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Praha 2, 128 08
    Czechia

    Active - Recruiting

  • Queen Mary Hospital / HKU

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories,
    Hong Kong

    Active - Recruiting

  • Aichi Cancer Center

    Nagoya-shi, Aichi 464-8681
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba 277-8577
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo 135-8550
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital

    Wakayama-shi, Wakayama 641-8510
    Japan

    Active - Recruiting

  • Cha Bundang Medical Center, Cha University

    Seongnam-si, Gyeonggi-do, 13496
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon-si Gyeonggi-do, 16499
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea St Vincents Hospital

    Suwon-si, Gyeonggi-do, 16247
    Korea, Republic of

    Active - Recruiting

  • Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

    Amsterdam, 1066 CX
    Netherlands

    Active - Recruiting

  • Sint Jansdal Ziekenhuis

    Harderwijk, 3844 DG
    Netherlands

    Active - Recruiting

  • Unidade Local de Saude de Braga, EPE

    Braga, 4710-243
    Portugal

    Active - Recruiting

  • Fundacao Champalimaud

    Lisboa, 1400-038
    Portugal

    Active - Recruiting

  • Hospital Cuf porto

    Porto, 4100-180
    Portugal

    Active - Recruiting

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072
    Portugal

    Active - Recruiting

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Active - Recruiting

  • National University Hospital

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560
    Turkey

    Active - Recruiting

  • Memorial Bahcelievler Hastanesi

    Istanbul, 34180
    Turkey

    Active - Recruiting

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • University of California Los Angeles

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut 06360
    United States

    Active - Recruiting

  • Medstar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Our Lady of the Lake Cancer Institute

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • Trinity Health Saint Joseph Mercy Ann Arbor

    Ann Arbor, Michigan 48106
    United States

    Active - Recruiting

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Oncology Central/South Texas

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Texas Oncology - Dallas Fort Worth

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • US Oncology Research Investigational Products Center

    Irving, Texas 75063
    United States

    Active - Recruiting

  • Texas Oncology Northeast Texas

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Virginia Cancer Specialists PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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