Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
NCT ID: NCT04794699
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
180 participants
INTERVENTIONAL
2021-04-14
2027-03-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation Monotherapy (Solid Tumors)
IDE397
IDE397 dosed orally
Part 2: Monotherapy Dose Expansion (NSCLC, EG and Urothelial)
IDE397
IDE397 dosed orally
Part 3: Combination Dose Escalation with docetaxel or paclitaxel (NSCLC, EG and Urothelial)
IDE397
IDE397 dosed orally
Docetaxel
Intravenous infusion
Paclitaxel
Intravenous infusion
Part 4: Combination Dose Expansion with docetaxel or paclitaxel (NSCLC, EG and Urothelial)
IDE397
IDE397 dosed orally
Docetaxel
Intravenous infusion
Paclitaxel
Intravenous infusion
Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (Urothelial)
IDE397
IDE397 dosed orally
Sacituzumab govitecan
Intravenous infusion
Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (Urothelial)
IDE397
IDE397 dosed orally
Sacituzumab govitecan
Intravenous infusion
Interventions
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IDE397
IDE397 dosed orally
Docetaxel
Intravenous infusion
Paclitaxel
Intravenous infusion
Sacituzumab govitecan
Intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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IDEAYA Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Jasgit Sachdev, MD
Role: STUDY_DIRECTOR
IDEAYA Biosciences
Locations
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Honor Health Research Institute
Scottsdale, Arizona, United States
Rockefeller Cancer Institute
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Hoag Memorial Hospital
Newport Beach, 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
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 Eugène Marquis
Rennes, , 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
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, Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taipei, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Maroof Khan Zafar
Role: primary
New Patient Services
Role: primary
Estefania Bobe Cortes
Role: primary
Carol Goldener
Role: primary
Kailene Sullivan
Role: primary
Benjamin Herzberg, MD
Role: primary
Christina Seunath
Role: primary
askSARAH
Role: primary
Jordi Rodon, MD
Role: primary
Jia Liu
Role: primary
Antoine Italiano
Role: primary
Carlos Gomez-Roca
Role: primary
Laurent Greillier
Role: primary
Thibault De la Motte Rouge
Role: primary
Frank Knauer
Role: primary
Ji-Youn Han
Role: primary
Joo-Hang Kim
Role: primary
Ki Hyeong Lee
Role: primary
Hye Ryun Kim
Role: primary
Changmin Choi
Role: primary
Montserrat Pequera Juvany
Role: primary
Elisa Lorente
Role: primary
Marta Benitez
Role: primary
Jorge Mercado
Role: primary
Laura Bailach
Role: primary
Ya-Zong Hsu
Role: primary
Chia-Chi Lin
Role: primary
Other Identifiers
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IDE397-001
Identifier Type: -
Identifier Source: org_study_id