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A Phase 1/2 Study of Anvumetostat in Combination With IDE397 in Participants With Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors
Sponsor: Amgen
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 Anvumetostat 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 anvumetostat in combination with IDE397 in adult participants with metastatic or locally advanced MTAP-null Non-Small-Cell Lung Cancer (NSCLC).
Official title: A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Anvumetostat in Combination With IDE397 in Subjects With Advanced MTAP-null Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2023-08-01
Completion Date
2026-04-01
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
Anvumetostat
Administered PO
IDE397
Administered PO
Locations (27)
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
Astera Cancer Care
East Brunswick, New Jersey, 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, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan