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Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion Summary This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and anti-tumor activity of IDE397 as a single agent and in combination with docetaxel, paclitaxel, gemcitabine/nab-paclitaxel and pemetrexed in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy or for whom no curative therapy is available. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).
View Eligibility Criteria Eligibility Criteria Inclusion Criteria: Participant must be at least 18 years of age Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy Have evidence of homozygous loss of MTAP or MTAP deletion Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns Measurable disease ECOG performance status <= 1 Adequate organ function Able to swallow and retain orally administered study treatment Recovery from acute effects of prior therapy Able to comply with contraceptive/barrier requirements Exclusion Criteria: Known symptomatic brain metastases Known primary CNS malignancy Current active liver or biliary disease Impairment of gastrointestinal (GI) function Active uncontrolled infection Clinically significant cardiac abnormalities Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry Radiation therapy within 2 weeks prior to study entry Prior irradiation to >25% of the bone marrow Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers Currently receiving another investigational study drug. Known or suspected hypersensitivity to IDE397/excipients or components
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 37 Locations for this study
Honor Health Research Institute Scottsdale Arizona, 85258, United States
University of Arkansas for Medical Sciences Little Rock Arkansas, 72205, United States
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City of Hope Duarte California, 91010, United States
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Providence Medical Group Santa Rosa California, 95403, United States
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Advent Health Celebration Florida, 34747, United States
Orlando Health Cancer Institute Orlando Florida, 32806, United States
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Indiana University Health Hospital Indianapolis Indiana, 46202, United States
Markey Cancer Center Lexington Kentucky, 40536, United States
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland, 21287, United States
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Dana Farber Cancer Institute Boston Massachusetts, 02115, United States
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Barbara Ann Karmanos Cancer Institute Detroit Michigan, 48201, United States
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Columbia University Medical Center - Herbert Irving Pavilion New York New York, 10032, United States
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Weill Cornell Medical College New York New York, 10065, United States
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Stephenson Cancer Center Oklahoma City Oklahoma, 73104, United States
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LifeSpan - Brown University Providence Rhode Island, 02906, United States
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SCRI Oncology Partners Nashville Tennessee, 37203, United States
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MD Anderson Houston Texas, 77030, United States
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Next Oncology San Antonio Texas, 78229, United States
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Swedish Cancer Institute Seattle Washington, 98104, United States
The Kinghorn Cancer Centre, St Vincent's Health Network Sydney Darlinghurst New South Wales, 02010, Australia
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Southern Oncology Clinical Research Unit Bedford Park South Australia, 05042, Australia
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Institut Bergonie Bordeaux Bordeaux Cedex, 33076, France
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Institut Claudius Regaud - IUCT-Oncopole Toulouse Cedex 9, 31059, France
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Hôpital Timone Marseille , 13005, France
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Centre Eugène Marquis Rennes , 35000, France
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Universitaetsklinikum Hamburg-Eppendorf (UKE) Hamburg , 20246, Germany
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Chungbuk National University Hospital Cheongju-si Chungcheongbuk-Do, 28644, Korea, Republic of
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National Cancer Center Goyang-si Gyeonggi, 10408, Korea, Republic of
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CHA University - Bundang Medical Center Seongnam-si Gyeonggi, 28644, Korea, Republic of
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Sevrance Hospital Seoul , 03722, Korea, Republic of
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Asan Medical Center Seoul , 05505, Korea, Republic of
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Vall Hebron Institute of Oncology Barcelona , 08035, Spain
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Hospital Universitario 12 de Octubre (H12O) Madrid , 28041, Spain
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START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC) Madrid , 28050, Spain
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NEXT Madrid, Universitary Hospital QuironSAlud Madrid , 28223, Spain
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Instituto Valenciano de Oncología (IVO) Valencia , 46009, Spain
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National Cheng Kung University Hospital Tainan , 704, Taiwan
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National Taiwan University Hospital Taipei , 100, Taiwan
More Info How clear is this clinincal trial information?
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