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Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
Sponsor: IDEAYA Biosciences
Summary
This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).
Official title: An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
169
Start Date
2021-04-14
Completion Date
2027-02-04
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
IDE397
IDE397 dosed orally
Sacituzumab govitecan
Intravenous infusion
Locations (37)
Honor Health Research Institute
Scottsdale, Arizona, United States
Rockefeller Cancer Institute
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Indiana University Health Hospital
Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
LifeSpan - Brown University
Providence, Rhode Island, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States
Next Oncology
San Antonio, Texas, United States
Swedish Cancer Institute
Seattle, Washington, United States
The Kinghorn Cancer Centre, St Vincent's Health Network Sydney
Darlinghurst, New South Wales, Australia
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia
Institut Bergonie
Bordeaux, Bordeaux Cedex, France
Institut Claudius Regaud - IUCT-Oncopole
Toulouse, Cedex 9, France
Hôpital Timone
Marseille, Marseille, France
Centre Georges Francois LeClerc
Dijon, France
Centre Eugène Marquis
Rennes, France
Gustave Roussy
Villejuif, France
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
CHA University - Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Sevrance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Universitario 12 de Octubre (H12O)
Madrid, Spain
START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)
Madrid, Spain
NEXT Madrid, Universitary Hospital QuironSAlud
Madrid, Spain
Instituto Valenciano de Oncología (IVO)
Valencia, Spain
National Cheng Kung University Hospital
Tainan, Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taipei, Taiwan