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

NCT ID NCT04794699

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

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.

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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

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