Clinical trial NCT06593522: A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC (MTAPESTRY 201)
Official title: A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects With Methylthioadenosine Phosphorylase (MTAP)-Deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: MTAP-deleted NSCLC
Keywords: Oncology
AMG 193
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 Criteria:

* 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.

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

Primary outcomes:
measure: Objective Response (OR) per RECIST 1.1
timeFrame: Up to 35 months
measure: 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)
timeFrame: Up to 35 months
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 35 months
measure: Number of Participants Experiencing Events of Interest (EOIs)
timeFrame: Up to 35 months
measure: Maximum Concentration (Cmax) of AMG 193
timeFrame: 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
measure: Time to Cmax (Tmax) of AMG 193
timeFrame: 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
measure: Area Under The Concentration-time Curve (AUC) of AMG 193
timeFrame: 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:
measure: Disease Control (DC) by BICR
timeFrame: Up to 35 months
measure: Duration of Response (DOR) by BICR
timeFrame: Up to 35 months
measure: Time to Response (TTR) by BICR
timeFrame: Up to 35 months
measure: Progression-free Survival (PFS) by BICR
timeFrame: Up to 35 months
measure: OR by Investigator's Assessment
timeFrame: Up to 35 months
measure: DC by Investigator's Assessment
timeFrame: Up to 35 months
measure: DOR by Investigator's Assessment
timeFrame: Up to 35 months
measure: TTR by Investigator's Assessment
timeFrame: Up to 35 months
measure: PFS by Investigator's Assessment
timeFrame: Up to 35 months
measure: Overall Survival (OS)
timeFrame: Up to 35 months
measure: Number of Participants Experiencing TEAEs
timeFrame: Up to 35 months
measure: Cmax of AMG 193
timeFrame: 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
measure: Tmax of AMG 193
timeFrame: 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
measure: AUC of AMG 193
timeFrame: 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
measure: Change in Quality of life (QoL) per The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ)-C30
timeFrame: Up to 12 months
measure: Change in QoL per Quality of Life Questionnaire-Lung Cancer 13 (QLQ LC13)
timeFrame: Up to 12 months
measure: Change in QoL per European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L)
timeFrame: Up to 12 months
measure: Overall Health Status per Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Up to 12 months
measure: Overall Health Status per The Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Duarte
country: United States
facility: City of Hope Orange County Lennar Foundation Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Norwich
country: United States
facility: Eastern Connecticut Hematology and Oncology Associates
state: Connecticut
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Cancer Institute
state: Louisiana
city: Ann Arbor
country: United States
facility: Trinity Health Saint Joseph Mercy Ann Arbor
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Nashville
country: United States
facility: Sarah Cannon Research Institute Oncology Partners
state: Tennessee
city: Nashville
country: United States
facility: United States Oncology Regulatory Affairs Corporate Office
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology Central/South Texas
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Fort Worth
state: Texas
city: Irving
country: United States
facility: US Oncology Research Investigational Products Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology Northeast Texas
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists PC
state: Virginia
city: St Leonards
country: Australia
facility: GenesisCare -North Shore Oncology
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
state: Queensland
city: Salvador
country: Brazil
facility: Núcleo de Oncologia da Bahia
state: Bahia
city: Natal
country: Brazil
facility: Liga Norte-Riograndense Contra O Cancer
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio 12 Hospital de Amor de Barretos
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer Estado SP Icesp
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Fundacao Antonio Prudente - Hosp AC Camargo
state: São Paulo
city: São José do Rio Preto
country: Brazil
facility: Fund Fac Reg Med Sao Jose Rio Preto
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educacao Pesquisa e Gestao em Saude
city: São Paulo
country: Brazil
facility: Centro Paulista de Oncologia
city: Montreal
country: Canada
facility: McGill University Health Centre Glen Site
state: Quebec
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary hospital of Fujian Medical University
state: Fujian
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital Of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Praha 4
country: Czechia
facility: Fakultni Thomayerova nemocnice
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
state: Wakayama
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Cha Bundang Medical Center, Cha University
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Suwon-si Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea St Vincents Hospital
city: Amsterdam
country: Netherlands
facility: Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
city: Harderwijk
country: Netherlands
facility: Sint Jansdal Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Braga
country: Portugal
facility: Unidade Local de Saude de Braga, EPE
city: Lisboa
country: Portugal
facility: Fundacao Champalimaud
city: Porto
country: Portugal
facility: Hospital Cuf porto
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Adana
country: Turkey
facility: Adana Sehir Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Memorial Bahcelievler Hastanesi
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: