Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion

Running, not enrolling · Phase 1

Conditions studied: Solid Tumor

In brief

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).

Key facts

Study ID

NCT04794699

Run by

IDEAYA Biosciences

People needed

169

Starts

2021-04-14

Expected to finish

2027-02-04

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Honor Health Research Institute — Scottsdale, Arizona, United States
• Rockefeller Cancer Institute — Little Rock, Arkansas, United States
• City of Hope — Duarte, California, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Indiana University Health Hospital — Indianapolis, Indiana, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Columbia University Medical Center - Herbert Irving Pavilion — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• LifeSpan - Brown University — Providence, Rhode Island, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• MD Anderson — Houston, Texas, United States
• Next Oncology — San Antonio, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• The Kinghorn Cancer Centre, St Vincent's Health Network Sydney — Darlinghurst, New South Wales, Australia
• Southern Oncology Clinical Research Unit — Bedford Park, South Australia, Australia
• Institut Bergonie — Bordeaux, Bordeaux Cedex, France
• Institut Claudius Regaud - IUCT-Oncopole — Toulouse, Cedex 9, France
• Hôpital Timone — Marseille, Marseille, France
• Centre Georges Francois LeClerc — Dijon, France
• Centre Eugène Marquis — Rennes, France
• Gustave Roussy — Villejuif, France
• Universitaetsklinikum Hamburg-Eppendorf (UKE) — Hamburg, Germany
• National Cancer Center — Goyang-si, Gyeonggi-do, South Korea

Full record on ClinicalTrials.gov

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