Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

Last updated: November 7, 2025
Sponsor: IDEAYA Biosciences
Overall Status: Active - Recruiting

Phase

1

Condition

Neuroblastoma

Neoplasms

Bladder Cancer

Treatment

Docetaxel

IDE397

Sacituzumab govitecan

Clinical Study ID

NCT04794699
IDE397-001
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 oftreatment 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

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 sacituzumabgovitecan

  • 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 CYP3A4/5inhibitors or inducers

  • Currently receiving another investigational study drug.

  • Known or suspected hypersensitivity to IDE397/excipients or components

Study Design

Total Participants: 180
Treatment Group(s): 4
Primary Treatment: Docetaxel
Phase: 1
Study Start date:
April 14, 2021
Estimated Completion Date:
March 30, 2027

Connect with a study center

  • The Kinghorn Cancer Centre, St Vincent's Health Network Sydney

    Darlinghurst, New South Wales 02010
    Australia

    Site Not Available

  • The Kinghorn Cancer Centre, St Vincent's Health Network Sydney

    Darlinghurst 2169378, New South Wales 2155400 02010
    Australia

    Active - Recruiting

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia 05042
    Australia

    Site Not Available

  • Southern Oncology Clinical Research Unit

    Bedford Park 2076918, South Australia 2061327 05042
    Australia

    Completed

  • Institut Bergonie

    Bordeaux, Bordeaux Cedex 33076
    France

    Site Not Available

  • Institut Bergonie

    Bordeaux 3031582, Bordeaux Cedex 33076
    France

    Active - Recruiting

  • Institut Claudius Regaud - IUCT-Oncopole

    Toulouse, Cedex 9 31059
    France

    Site Not Available

  • Institut Claudius Regaud - IUCT-Oncopole

    Toulouse 2972315, Cedex 9 31059
    France

    Active - Recruiting

  • Hôpital Timone

    Marseille 2995469, Marseille 13005
    France

    Active - Recruiting

  • Hôpital Timone

    Marseille, 13005
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes, 35000
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes 2983990, 35000
    France

    Active - Recruiting

  • Universitaetsklinikum Hamburg-Eppendorf (UKE)

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitaetsklinikum Hamburg-Eppendorf (UKE)

    Hamburg 2911298, 20246
    Germany

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbuk-Do 28644
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si, Gyeonggi 10408
    Korea, Republic of

    Site Not Available

  • CHA University - Bundang Medical Center

    Seongnam-si, Gyeonggi 28644
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Sevrance Hospital

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center

    Goyang-si 1842485, Gyeonggi-do 1841610 10408
    South Korea

    Active - Recruiting

  • CHA University - Bundang Medical Center

    Seongnam-si 1897000, Gyeonggi-do 1841610 28644
    South Korea

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju-si 1845604, North Chungcheong 1845106 28644
    South Korea

    Active - Recruiting

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Sevrance Hospital

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

  • Vall Hebron Institute of Oncology

    Barcelona, 08035
    Spain

    Site Not Available

  • Vall Hebron Institute of Oncology

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre (H12O)

    Madrid, 28041
    Spain

    Active - Recruiting

  • NEXT Madrid, Universitary Hospital QuironSAlud

    Madrid, 28223
    Spain

    Active - Recruiting

  • START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre (H12O)

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • NEXT Madrid, Universitary Hospital QuironSAlud

    Madrid 3117735, 28223
    Spain

    Active - Recruiting

  • START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)

    Madrid 3117735, 28050
    Spain

    Active - Recruiting

  • Instituto Valenciano de Oncología (IVO)

    Valencia, 46009
    Spain

    Site Not Available

  • Instituto Valenciano de Oncología (IVO)

    Valencia 2509954, 46009
    Spain

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan 1668355, Tainan 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, Taipei 7280290 100
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • Honor Health Research Institute

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Honor Health Research Institute

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Completed

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Rockefeller Cancer Institute

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Providence Medical Group

    Santa Rosa, California 95403
    United States

    Site Not Available

  • City of Hope

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • Hoag Memorial Hospital

    Newport Beach 5376890, California 5332921 92663
    United States

    Active - Recruiting

  • Providence Medical Group

    Santa Rosa 5393287, California 5332921 95403
    United States

    Site Not Available

  • Advent Health

    Celebration, Florida 34747
    United States

    Site Not Available

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Site Not Available

  • Advent Health

    Celebration 4150394, Florida 4155751 34747
    United States

    Site Not Available

  • Orlando Health Cancer Institute

    Orlando 4167147, Florida 4155751 32806
    United States

    Active - Recruiting

  • Indiana University Health Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University Health Hospital

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Completed

  • Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Markey Cancer Center

    Lexington 4297983, Kentucky 6254925 40536
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Barbara Ann Karmanos Cancer Institute

    Detroit 4990729, Michigan 5001836 48201
    United States

    Site Not Available

  • Columbia University Medical Center - Herbert Irving Pavilion

    New York, New York 10032
    United States

    Active - Recruiting

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • Columbia University Medical Center - Herbert Irving Pavilion

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • Weill Cornell Medical College

    New York 5128581, New York 5128638 10065
    United States

    Completed

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Stephenson Cancer Center

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Active - Recruiting

  • LifeSpan - Brown University

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • LifeSpan - Brown University

    Providence 5224151, Rhode Island 5224323 02906
    United States

    Completed

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • The Sarah Cannon Research Institute/Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • MD Anderson

    Houston, Texas 77030
    United States

    Site Not Available

  • Next Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • MD Anderson

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Next Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Completed

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

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