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 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) Intracranial Disease Control (IDC) per RANO-BM Up to approximately 3 years 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 (80)
Narodowy Instytut Onkologii im Marii Slodowskiej-Curie Panstwowy Instytut Badawczy
🇵🇱Gliwice, Poland
Comprehensive Blood and Cancer Center
🇺🇸Bakersfield, California, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
City of Hope Orange County Lennar Foundation Cancer 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
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