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Treatment for solid tumors with MTAP deletion using IDE397

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

Phase 1 Interventional IDEAYA Biosciences · NCT04794699

This study is testing a new drug called IDE397 to see if it can help adults with advanced solid tumors that have a specific genetic change and have not responded to standard treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorIDEAYA Biosciences Industry-sponsored
Drugs / interventionssacituzumab, Radiation
Locations38 sites (Scottsdale, Arizona and 37 other locations)
Trial IDNCT04794699 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label, multicenter study evaluates the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of IDE397, a small molecule inhibitor targeting MAT2A, in adult patients with advanced solid tumors that have a homozygous loss of MTAP. The study includes a dose escalation and expansion phase, where IDE397 is administered alone or in combination with other anticancer agents like taxanes or sacituzumab govitecan. Participants must have tumors that have progressed after standard treatments and be willing to undergo biopsies for research purposes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors exhibiting MTAP deletion and who have progressed on prior treatments.

Not a fit: Patients with symptomatic brain metastases, primary CNS malignancies, or those who have previously been treated with MAT2A inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are currently unresponsive to standard therapies.

How similar studies have performed: While this approach is novel in targeting MTAP deletion with IDE397, similar studies targeting specific genetic alterations in solid tumors have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
* Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
* 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 CYP3A4/5 inhibitors or inducers
* Currently receiving another investigational study drug.
* Known or suspected hypersensitivity to IDE397/excipients or components

Where this trial is running

Scottsdale, Arizona and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorMAT2A9p21CDKN2AMTAPSolid TumorsPRMT5SAM
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.