AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104).
- Conditions
- Thoracic TumorsNon-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06333951
- Lead Sponsor
- Amgen
- Brief Summary
The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subprotocol B: NSCLC With KRasG12C Mutation AMG 193 Participants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of AMG 193 and sotorasib PO Subprotocol C: NSCLC With Brain Metastases AMG 193 Participants with MTAP-deleted NSCLC with brain metastases will receive AMG 193 PO Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A AMG 193 Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV) Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A Carboplatin Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV) Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A Paclitaxel Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV) Subprotocol A: Non-Small Cell Lung Cancer (NSCLC) Arm A Pembrolizumab Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 orally (PO) and carboplatin, paclitaxel, and pembrolizumab intravenously (IV) Subprotocol A: NSCLC Arm B AMG 193 Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV Subprotocol A: NSCLC Arm B Carboplatin Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV Subprotocol A: NSCLC Arm B Pembrolizumab Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV Subprotocol A: NSCLC Arm B Pemetrexed Participants with MTAP-deleted NSCLC will receive a regimen of AMG 193 PO and carboplatin, pemetrexed, and pembrolizumab IV Subprotocol A: NSCLC Arm C AMG 193 Participants with MTAP-deleted NSCLC will receive a combination of AMG 193 PO and pembrolizumab IV Subprotocol A: NSCLC Arm C Pembrolizumab Participants with MTAP-deleted NSCLC will receive a combination of AMG 193 PO and pembrolizumab IV Subprotocol B: NSCLC With KRasG12C Mutation Sotorasib Participants with MTAP-deleted NSCLC and KRasG12C mutation will receive a combination of AMG 193 and sotorasib PO
- Primary Outcome Measures
Name Time Method Number of Participants Experiencing Serious Adverse Events (SAE) Up to approximately 3 years An SAE is defined as any AE that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the participant or may require medical or surgical intervention to prevent any of the outcomes listed above.
Number of Participants Experiencing Dose Limiting Toxicities (DLT) Up to approximately 21 days Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE) Up to approximately 3 years TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
- Secondary Outcome Measures
Name Time Method Intracranial Disease Control (IDC) per RANO-BM Up to approximately 3 years Progression-free Survival (PFS) per RECIST v1.1 Up to approximately 3 years Time to Response (TTR) per RECIST v1.1 Up to approximately 3 years Duration of Response (DOR) per RECIST v1.1 Up to approximately 3 years Intracranial objective response (IOR) per Response Assessment in Neuro Oncology Brain Metastases (RANO-BM ) Up to approximately 3 years Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Up to approximately 3 years Overall Survival (OS) per RECIST v1.1 Up to approximately 3 years Disease Control (DC) per RECIST v1.1 Up to approximately 3 years Time to Maximum Plasma Concentration (tmax) of AMG 193 Up to Day 1 of Cycle 5 (one cycle = 21 days) Time to Intracranial Radiation Therapy per RANO-BM Up to approximately 3 years Maximum Plasma Concentration (Cmax) of AMG 193 Up to Day 1 of Cycle 5 (one cycle = 21 days) Area Under the Plasma Concentration-time Curve (AUC) of AMG 193 Up to Day 1 of Cycle 5 (one cycle = 21 days) Intracranial Duration of Response (IDOR) per RANO-BM Up to approximately 3 years
Trial Locations
- Locations (64)
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
City of Hope National Medical 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
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
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, 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
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
🇧🇪Liege, Belgium
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira 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
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, 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
Thoraxklinik Heidelberg
🇩🇪Heidelberg, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, 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
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
ðŸ‡ðŸ‡°Shatin, New Territories, Hong Kong
Fondazione IRCCS Istituto Nazionale dei Tumori
🇮🇹Alessandria, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano (MI), Italy
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
🇮🇹Verona, Italy
Aichi Cancer Center
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center
🇯🇵Sunto-gun, Shizuoka, Japan
Wakayama Medical University Hospital
🇯🇵Wakayama-shi, Wakayama, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Radboud Universitair Medisch Centrum
🇳🇱Nijmegen, Netherlands
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
Narodowy Instytut Onkologii im Marii Slodowskiej Curie Panstwowy Instytut Badawczy
🇵🇱Gliwice, Poland
Futuremeds Spolka z Ograniczona Odpowiedzialnoscia
🇵🇱Kraków, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
Centrum Medyczne Hope Clinic Sebastian Szklener
🇵🇱Lublin, Poland
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan