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New drug IDE397 targets Hard-to-Treat cancers in early trial

NCT ID NCT04794699

Disease control Sponsor: IDEAYA Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 1 trial tests a new drug called IDE397, alone or with another drug (sacituzumab govitecan), in adults with advanced solid tumors that have a specific genetic change (MTAP deletion) and have stopped responding to standard treatments. The study aims to find safe doses and check for early signs of tumor shrinkage. About 169 participants will take part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IDE397 (a MAT2A inhibitor) and sacituzumab govitecan (a chemotherapy drug)
What this could lead to
If successful, this could lead to a new treatment option for people with certain advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early Phase 1 trial, so the drug may not be safe or effective. It is only for patients with a specific genetic marker (MTAP deletion), and side effects are unknown.
Why investors are watching

Ideaya Biosciences is testing IDE397, a drug that blocks a protein called MAT2A, in people with advanced solid tumors that lack a gene called MTAP. This is a Phase 1 trial, meaning the main goal is to check safety and find the right dose, but it also tracks whether the drug shrinks tumors. For a small company like Ideaya, this readout is a key test of whether its lead drug works in a broad group of cancers, which could shape its future value.

If it works: If the trial shows IDE397 is safe and produces signs of tumor shrinkage, Ideaya could move the drug into later-stage studies. That progress might attract partners or funding to continue development.

If it fails: Phase 1 trials often fail because the drug proves too toxic or shows little effect. A poor result or a delay in enrollment could set back Ideaya's pipeline and reduce investor confidence.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

169 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lung neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, 05505, South Korea

  • CHA University - Bundang Medical Center

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

  • Centre Eugène Marquis

    Rennes, 35000, France

  • Centre Georges Francois LeClerc

    Dijon, France

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • City of Hope

    Duarte, California, 91010, United States

  • Columbia University Medical Center - Herbert Irving Pavilion

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Gustave Roussy

    Villejuif, France

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258, United States

  • Hospital Universitario 12 de Octubre (H12O)

    Madrid, 28041, Spain

  • Hôpital Timone

    Marseille, Marseille, 13005, France

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202, United States

  • Institut Bergonie

    Bordeaux, Bordeaux Cedex, 33076, France

  • Institut Claudius Regaud - IUCT-Oncopole

    Toulouse, Cedex 9, 31059, France

  • Instituto Valenciano de Oncología (IVO)

    Valencia, 46009, Spain

  • LifeSpan - Brown University

    Providence, Rhode Island, 02906, United States

  • MD Anderson

    Houston, Texas, 77030, United States

  • NEXT Madrid, Universitary Hospital QuironSAlud

    Madrid, 28223, Spain

  • National Cancer Center

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

  • National Cheng Kung University Hospital

    Tainan, Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, Taipei, 100, Taiwan

  • Next Oncology

    San Antonio, Texas, 78229, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Rockefeller Cancer Institute

    Little Rock, Arkansas, 72205, United States

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

    Madrid, 28050, Spain

  • Samsung Medical Center

    Seoul, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    Seoul, South Korea

  • Sevrance Hospital

    Seoul, 03722, South Korea

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia, 05042, Australia

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Swedish Cancer Institute

    Seattle, Washington, 98104, United States

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

    Darlinghurst, New South Wales, 02010, Australia

  • Universitaetsklinikum Hamburg-Eppendorf (UKE)

    Hamburg, 20246, Germany

  • Weill Cornell Medical College

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.