A Phase 1/2 Study of AMG 193 in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
- Conditions
- MTAP-null Non-Small-Cell Lung CancerMTAP-null Solid Tumors
- Interventions
- Registration Number
- NCT05975073
- Lead Sponsor
- Amgen
- Brief Summary
The main aims of this study are to evaluate the safety and tolerability, and to determine the maximum tolerated dose (MTD) or the recommended combination dose of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null solid tumors, and to evaluate the preliminary anti-tumor activity of AMG 193 in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2: Dose Expansion of AMG 193 Combined With IDE397 AMG 193 AMG 193 and IDE397 will be administered PO in cycles of 21 days. Part 2: Dose Expansion of AMG 193 Combined With IDE397 IDE397 AMG 193 and IDE397 will be administered PO in cycles of 21 days. Part 1: Dose Exploration of AMG 193 Combined With IDE397 AMG 193 Participants will receive escalating doses of AMG 193 and IDE397 administered orally (PO) in cycles of 21 days. Part 1: Dose Exploration of AMG 193 Combined With IDE397 IDE397 Participants will receive escalating doses of AMG 193 and IDE397 administered orally (PO) in cycles of 21 days.
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) Day 1 up to Day 21 Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Day 1 up to approximately 2.5 years Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs) Day 1 up to approximately 2.5 years Part 2: Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Day 1 up to approximately 2.5 years
- Secondary Outcome Measures
Name Time Method Part 1 and 2: Maximal Plasma Concentration (Cmax) of AMG 193 Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) Part 1 and 2: Cmax of IDE397 Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of AMG 193 Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) Part 1 and 2: Tmax of IDE397 Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) Parts 1 and 2: Area Under The Curve (AUC) After Single Dose of AMG 193 Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) Parts 1 and 2: Area Under The Curve (AUC) After Multiple Doses of AMG 193 Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) Parts 1 and 2: AUC After Single Dose of IDE397 Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) Parts 1 and 2: AUC After Multiple Doses of IDE397 Day 1 pre-dose up to Cycle 5 (Cycle= 21 days) Parts 1: Overall Response per RECIST 1.1 Day 1 up to end-of-study (EOS) (approximately 2.5 years) Parts 1 and 2: Disease Control Rate Day 1 up to EOS (approximately 2.5 years) Parts 1 and 2: Time to Response (TTR) Day 1 up to EOS (approximately 2.5 years) Parts 1 and 2: Duration of Response (DOR) Day 1 up to EOS (approximately 2.5 years) Parts 1 and 2: Duration of Stable Disease Day 1 up to EOT (approximately 6 months) Parts 1 and 2: Progression-free Survival (PFS) Day 1 up to EOS (approximately 2.5 years) Parts 1 and 2: Overall Survival (OS) Day 1 up to EOS (approximately 2.5 years) Part 2: Number of Participants Experiencing TEAEs Day 1 up to approximately 2.5 years Any clinically significant changes in vital signs, electrocardiogram (ECG), or clinical laboratory test results will be recorded as adverse events
Part 2: Number of Participants Experiencing SAEs Day 1 up to approximately 2.5 years Parts 1 and 2: Change From Baseline in Symmetric Dimethylation of Arginine (SDMA) in Blood Baseline (Day 1) to EOT plus 30 days (approximately 7 months)
Trial Locations
- Locations (27)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Astera Cancer Care
🇺🇸East Brunswick, New Jersey, United States
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Sarah Cannon Research Institute
🇺🇸Denver, Colorado, United States
Community Health Network MD Anderson Cancer Center - North
🇺🇸Indianapolis, Indiana, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Health Partners Cancer Center at Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
🇺🇸New York, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
Prisma Health Upstate
🇺🇸Greenville, South Carolina, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Next Oncology
🇺🇸Irving, Texas, United States
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Rigshospitalet
🇩🇰Copenhagen, Denmark
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of