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

NCT06593522 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 20230153
• Study Type: interventional
• Target: 61
• Locations: 16 countries
• Sites: 91

Brief Summary

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

Conditions

MTAP-deleted NSCLC

Keywords

Oncology; anvumetostat

Outcome Measures

Primary Outcomes (7)

• Objective Response (OR) per RECIST 1.1

  Up to 35 months

• Objective response (OR) Measured by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and Assessed per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)

  Up to 35 months

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  Up to 35 months

• Number of Participants Experiencing Events of Interest (EOIs)

  Up to 35 months

• Maximum Concentration (Cmax) of anvumetostat

  Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

• Time to Cmax (Tmax) of anvumetostat

  Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

• Area Under The Concentration-time Curve (AUC) of anvumetostat

  Cycle 1: Day 1 and Day 15 pre-dose, 0.5 hours, 1 hour, 2 hours, 4 hours, and 6 hours post-dose; Cycle 2: Day 1 and Day 15 pre-dose; Cycles 3-5: Day 1 pre-dose

Secondary Outcomes (19)

• Disease Control (DC) by BICR

  Up to 35 months

• Duration of Response (DOR) by BICR

  Up to 35 months

• Time to Response (TTR) by BICR

  Up to 35 months

• Progression-free Survival (PFS) by BICR

  Up to 35 months

• OR by Investigator's Assessment

  Up to 35 months

Study Arms (2)

Part 1: Dose Evaluation

EXPERIMENTAL

Participants will be randomized to receive one of 2 active dose levels of anvumetostat orally (PO) daily (QD) in 28 days cycles. Part 1 of the study will determine the recommended phase 2 dose (RP2D).

Drug: anvumetostat

Part 2: Dose Expansion

EXPERIMENTAL

Participants will receive anvumetostat PO QD in 28-day cycles at the RP2D.

Drug: anvumetostat

Interventions

anvumetostat DRUG

Film-coated tablet

Part 1: Dose Evaluation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Amgen: lead

Study Sites (91)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

City of Hope Orange County Lennar Foundation Cancer Center

Duarte, California, 91010, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Hartford HealthCare Cancer Institute - Manchester

Plainville, Connecticut, 06062, United States

Location

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Our Lady of the Lake Cancer Institute

Baton Rouge, Louisiana, 70808, United States

Location

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan, 48106, United States

Location

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503, United States

Location

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, 37203, United States

Location

United States Oncology Regulatory Affairs Corporate Office

Nashville, Tennessee, 37203, United States

Location

Texas Oncology Central/South Texas

Austin, Texas, 78745, United States

Location

Sarah Cannon Research Institute

Dallas, Texas, 75230, United States

Location

Texas Oncology - Dallas Fort Worth

Dallas, Texas, 75246, United States

Location

US Oncology Research Investigational Products Center

Irving, Texas, 75063, United States

Location

Texas Oncology Northeast Texas

Tyler, Texas, 75702, United States

Location

Virginia Cancer Specialists PC

Fairfax, Virginia, 22031, United States

Location

GenesisCare -North Shore Oncology

St Leonards, New South Wales, 2065, Australia

Location

Calvary Mater Newcastle Hospital

Waratah, New South Wales, 2298, Australia

Location

Mater Hospital Brisbane

South Brisbane, Queensland, 4101, Australia

Location

Cancer Research South Australia

Adelaide, South Australia, 5000, Australia

Location

Núcleo de Oncologia da Bahia

Salvador, Estado de Bahia, 40170-110, Brazil

Location

Liga Norte-Riograndense Contra O Cancer

Natal, Rio Grande do Norte, 59062-000, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91010-004, Brazil

Location

Fundacao pio xII Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

Fund Faculdade Regional Med Sao Jose Rio Preto

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

Location

Instituto do Cancer Estado SP Icesp

São Paulo, São Paulo, 01246-000, Brazil

Location

Fundacao Antonio Prudente - Hosp AC Camargo

São Paulo, São Paulo, 01509-900, Brazil

Location

Instituto de Educacao Pesquisa e Gestao em Saude

Rio de Janeiro, 22775-001, Brazil

Location

Centro Paulista de Oncologia

São Paulo, 04538-132, Brazil

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

William Osler Health System - Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre Glen Site

Montreal, Quebec, H4A 3J1, Canada

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350028, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450001, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Beijing Chest Hospital, Capital Medical University

Beijing, 101149, China

Location

Masarykuv onkologicky ustav

Brno, 656 53, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Fakultni Thomayerova nemocnice

Prague, 140 59, Czechia

Location

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Location

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, 135-8550, Japan

Location

Wakayama Medical University Hospital

Wakayama, Wakayama, 641-8510, Japan

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Riga East Clinical University Hospital

Riga, 1079, Latvia

Location

Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis

Amsterdam, 1066 CX, Netherlands

Location

Sint Jansdal Ziekenhuis

Harderwijk, 3844 DG, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Unidade Local de Saude de Braga, EPE

Braga, 4710-243, Portugal

Location

Fundacao Champalimaud

Lisbon, 1400-038, Portugal

Location

Hospital Cuf porto

Porto, 4100-180, Portugal

Location

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, 4200-072, Portugal

Location

National University Hospital

Singapore, 119074, Singapore

Location

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

Cha Bundang Medical Center, Cha University

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Ajou University Hospital

Suwon-si Gyeonggi-do, 16499, South Korea

Location

The Catholic University of Korea St Vincents Hospital

Suwon-si, Gyeonggi-do, 16247, South Korea

Location

Universitaetsspital Basel

Basel, 4031, Switzerland

Location

Hopitaux Universitaires de Geneve

Geneva, 1211, Switzerland

Location

Kantonsspital Sankt Gallen

Sankt Gallen, 9007, Switzerland

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, 01370, Turkey (Türkiye)

Location

Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

Ankara, 06560, Turkey (Türkiye)

Location

Ankara Bilkent Sehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

Location

Memorial Bahcelievler Hastanesi

Istanbul, 34180, Turkey (Türkiye)

Location

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, 34214, Turkey (Türkiye)

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

LA (2); BR (10); SG (2); AU (4); CA (5); HK (2); TU (5); JP (6); NL (3); CN (14); CZ (4); TW (3); US (20); KR (4); CH (3); PT (4)