Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

April 6, 2026 updated by: IDEAYA Biosciences

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 02010
        • The Kinghorn Cancer Centre, St Vincent's Health Network Sydney
    • South Australia
      • Bedford Park, South Australia, Australia, 05042
        • Southern Oncology Clinical Research Unit
  • France
      • Dijon, France
        • Centre Georges Francois Leclerc
      • Rennes, France, 35000
        • Centre Eugene Marquis
      • Villejuif, France
        • Gustave Roussy
    • Bordeaux Cedex
      • Bordeaux, Bordeaux Cedex, France, 33076
        • Institut Bergonie
    • Cedex 9
      • Toulouse, Cedex 9, France, 31059
        • Institut Claudius Regaud - IUCT-Oncopole
    • Marseille
      • Marseille, Marseille, France, 13005
        • Hôpital Timone
  • Germany
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf (UKE)
  • South Korea
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Sevrance Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, South Korea, 28644
        • CHA University - Bundang Medical Center
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Chungbuk National University Hospital
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre (H12O)
      • Madrid, Spain, 28050
        • START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC)
      • Madrid, Spain, 28223
        • NEXT Madrid, Universitary Hospital QuironSAlud
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncología (IVO)
  • Taiwan
    • Tainan
      • Tainan, Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
    • Taipei
      • Taipei, Taipei, Taiwan, 100
        • National Taiwan University Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health Research Institute
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Rockefeller Cancer Institute
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Health Cancer Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10032
        • Columbia University Medical Center - Herbert Irving Pavilion
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • LifeSpan - Brown University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson
      • San Antonio, Texas, United States, 78229
        • NEXT Oncology
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • Active second malignancy or history of another malignancy in the past 2 years
  • 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.
  • Known or suspected hypersensitivity to IDE397/excipients or components

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose Escalation Monotherapy (Solid Tumors)
Drug: IDE397
IDE397 dosed orally
Experimental: Part 2: Monotherapy Dose Expansion (NSCLC and Urothelial)
Drug: IDE397
IDE397 dosed orally
Experimental: Part 5: Combination Dose Escalation with sacituzumab govitecan (SG) (NSCLC and Urothelial)
Drug: IDE397
IDE397 dosed orally
Drug: Sacituzumab govitecan
Intravenous infusion
Experimental: Part 6: Combination Dose Expansion with sacituzumab govitecan (SG) (NSCLC and Urothelial)
Drug: IDE397
IDE397 dosed orally
Drug: Sacituzumab govitecan
Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting Toxicities (DLTs) of IDE397
Time Frame: 21 days following the first dose of IDE397
Incidence of DLTs of IDE397 will be determined
21 days following the first dose of IDE397
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
Time Frame: Approximately 2 years
MTD and RP2D of IDE397 will be determined
Approximately 2 years
Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan
Time Frame: 21 - 28 days following the first dose of IDE397
Incidence of DLTs of IDE397 in a combination setting will be determined
21 - 28 days following the first dose of IDE397
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan
Time Frame: Approximately 2 years
MTD and RP2D of IDE397 in a combination setting will be determined
Approximately 2 years
To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms
Time Frame: Approximately 2 years
Objective Response Rate (ORR) and Duration of Response (DoR)
Approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary anti-tumor activity in IDE397 escalation and combination escalation arms
Time Frame: Approximately 2 years
Objective response rate and duration of response will be assessed by Investigator using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Approximately 2 years
Plasma Pharmacokinetics of IDE397 and metabolite
Time Frame: Approximately 2 years
Pharmacokinetics of IDE397 and metabolite following single and multiple oral administration as a single agent and in combination with sacituzumab govitecan, will be determined
Approximately 2 years
Drug interaction between IDE397 and sacituzumab govitecan
Time Frame: Approximately 2 years
Pharmacokinetics of sacituzumab govitecan and relevant catabolism products
Approximately 2 years
Pharmacodynamic effect of IDE397 as a single agent and in combination with sacituzumab govitecan
Time Frame: Approximately 2 years
Changes in the levels of MAT2A pathway and PRMT5 pathway will be determined
Approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IDEAYA Biosciences

Investigators

  • Study Director: Jasgit Sachdev, MD, IDEAYA Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2021

Primary Completion (Estimated)

January 7, 2027

Study Completion (Estimated)

February 4, 2027

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDE397-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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