Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
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).
Checked against the public recordLast updated Apr 9, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- IDEAYA Biosciences
- Interventions being studied
- Drug: IDE397; Drug: Sacituzumab govitecan
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Honor Health Research InstituteScottsdale, Arizona
- Rockefeller Cancer InstituteLittle Rock, Arkansas
- City of HopeDuarte, California
- Orlando Health Cancer InstituteOrlando, Florida
- Indiana University Health HospitalIndianapolis, Indiana
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland
- Dana Farber Cancer InstituteBoston, Massachusetts
- Columbia University Medical Center - Herbert Irving PavilionNew York, New York
- Weill Cornell Medical CollegeNew York, New York
- Stephenson Cancer CenterOklahoma City, Oklahoma
- LifeSpan - Brown UniversityProvidence, Rhode Island
- Sarah Cannon Research InstituteNashville, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 9, 2026. Always confirm current availability with the study team.