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Brief Title: Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
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
Study ID: NCT04794699
Brief 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 other anticancer agents including taxanes (docetaxel, paclitaxel), or 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Honor Health Research Institute, Scottsdale, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope, Duarte, California, United States
Providence Medical Group, Santa Rosa, California, United States
Advent Health, Celebration, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Indiana University Health Hospital, Indianapolis, Indiana, United States
Markey Cancer Center, Lexington, Kentucky, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 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
SCRI Oncology Partners, 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, , France
Centre Eugène Marquis, Rennes, , France
Universitaetsklinikum Hamburg-Eppendorf (UKE), Hamburg, , Germany
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-Do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi, Korea, Republic of
CHA University - Bundang Medical Center, Seongnam-si, Gyeonggi, Korea, Republic of
Sevrance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Vall Hebron Institute of Oncology, Barcelona, , Spain
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, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Name: Jasgit Sachdev, MD
Affiliation: IDEAYA Biosciences
Role: STUDY_DIRECTOR