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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 9, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.