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NCT04794699Active, not recruitingPhase 1

Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

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

Source: ClinicalTrials.gov · Last updated 9 Apr 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
169 (actual)
First submitted
9 Mar 2021
Start date
14 Apr 2021
Primary completion date
7 Jan 2027
Lead sponsor
IDEAYA Biosciences
NCT number
NCT04794699

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 169
  • From 14 Apr 2021 to the primary completion date, 7 Jan 2027
  • 37 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
  • Systemic anti-cancer therapy, therapeutic antibody treatment, or major surgery within 4 weeks prior to study entry
  • Current radiation-related toxicity or radiation therapy within 2 weeks prior to study entry
  • Small molecule anti-cancer treatment 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
  • Require concomitant use of proton pump inhibitor
  • Currently receiving another investigational study drug.

Other illness

  • Known primary CNS malignancy
  • Current active liver or biliary disease
  • Impairment of gastrointestinal (GI) function
  • Active uncontrolled infection
  • Clinically significant cardiac abnormalities
  • Active second malignancy or history of another malignancy in the past 2 years
  • Known or suspected hypersensitivity to IDE397/excipients or components

Other

  • Known symptomatic brain metastases

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (37)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Southern Oncology Clinical Research Unit
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Bedford ParkAustraliaUnknown status
The Kinghorn Cancer Centre, St Vincent's Health Network Sydney
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DarlinghurstAustraliaUnknown status
Universitaetsklinikum Hamburg-Eppendorf (UKE)
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HamburgGermanyUnknown status
NEXT Madrid, Universitary Hospital QuironSAlud
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MadridSpainUnknown status
START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre (H12O)
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MadridSpainUnknown status
Instituto Valenciano de Oncología (IVO)
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ValenciaSpainUnknown status
Institut Bergonie
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BordeauxFranceUnknown status
Centre Georges François Leclerc
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DijonFranceUnknown status
Hôpital Timone
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MarseilleFranceUnknown status
Centre Eugène Marquis
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RennesFranceUnknown status
Institut Claudius Regaud - iUCT Oncopole
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ToulouseFranceUnknown status
Gustave Roussy
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VillejuifFranceUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
CHA University - Bundang Medical Center
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Seongnam-siSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Sevrance Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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BaltimoreUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
City of Hope
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DuarteUnited StatesUnknown status
MD Anderson
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HoustonUnited StatesUnknown status
Indiana University Health Hospital
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IndianapolisUnited StatesUnknown status
Rockefeller Cancer Institute
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Little RockUnited StatesUnknown status
Sarah Cannon Research Institute
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NashvilleUnited StatesUnknown status
Weill Cornell Medical College
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New YorkUnited StatesUnknown status
Columbia University Medical Center - Herbert Irving Pavilion
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New YorkUnited StatesUnknown status
Stephenson Cancer Center
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Oklahoma CityUnited StatesUnknown status
Orlando Health Cancer Institute
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OrlandoUnited StatesUnknown status
LifeSpan - Brown University
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ProvidenceUnited StatesUnknown status
NEXT Oncology
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San AntonioUnited StatesUnknown status
Honor Health Research Institute
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ScottsdaleUnited StatesUnknown status
Swedish Cancer Institute
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SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.