A Phase 2 Study of AMG 193 in Participants With MTAP-deleted Advanced NSCLC
- Registration Number
- NCT06593522
- Lead Sponsor
- Amgen
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted (Homozygous deletion of MTAP in the tumor tissue) non-small cell lung cancer
- 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.
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), KRAS proto-oncogene (KRAS).
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Dose Evaluation AMG 193 Participants will be randomized to receive one of 2 active dose levels of AMG 193 orally (PO) daily (QD) in 28 days cycles. Part 1 of the study will determine the recommended phase 2 dose (RP2D). Part 2: Dose Expansion AMG 193 Participants will receive AMG 193 PO QD in 28-day cycles at the RP2D.
- Primary Outcome Measures
Name Time Method 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 AMG 193 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 AMG 193 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 AMG 193 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 Outcome Measures
Name Time Method 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 DC by Investigator's Assessment Up to 35 months DOR by Investigator's Assessment Up to 35 months TTR by Investigator's Assessment Up to 35 months PFS by Investigator's Assessment Up to 35 months Overall Survival (OS) Up to 35 months Number of Participants Experiencing TEAEs Up to 35 months Cmax of AMG 193 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 Tmax of AMG 193 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 AUC of AMG 193 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 Change in Quality of life (QoL) per The European Organization for Research and Treatment of Cancer Quality of life Questionnaire (EORTC QLQ)-C30 Up to 12 months Change in QoL per Quality of Life Questionnaire-Lung Cancer 13 (QLQ LC13) Up to 12 months Change in QoL per European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) Up to 12 months Overall Health Status per Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Up to 12 months Overall Health Status per The Functional Assessment of Cancer Therapy - General (FACT-G) Up to 12 months
Trial Locations
- Locations (11)
City of Hope Orange County Lennar Foundation Cancer Center
🇺🇸Duarte, California, United States
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Eastern Connecticut Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
GenesisCare -North Shore Oncology
🇦🇺St Leonards, New South Wales, Australia
Calvary Mater Newcastle Hospital
🇦🇺Waratah, New South Wales, Australia
McGill University Health Centre Glen Site
🇨🇦Montreal, Quebec, Canada
Cancer and Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
City of Hope National Medical Center
🇺🇸Duarte, California, United States