NCT04794699Active, not recruitingPhase 1
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
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
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 169 (actual)
- First submitted
- 9 Mar 2021
- Start date
- 14 Apr 2021
- Primary completion date
- 7 Jan 2027
- Lead sponsor
- IDEAYA Biosciences
- Diseases
- Bladder cancer, Lung cancer
- NCT number
- NCT04794699
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 169
- From 14 Apr 2021 to the primary completion date, 7 Jan 2027
- 37 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- Known or suspected hypersensitivity to IDE397/excipients or components
Other
- Known symptomatic brain metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Southern Oncology Clinical Research Unit Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| The Kinghorn Cancer Centre, St Vincent's Health Network Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| Universitaetsklinikum Hamburg-Eppendorf (UKE) Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| NEXT Madrid, Universitary Hospital QuironSAlud Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| START Madrid-HM - Centro Integral Oncológico Clara Campal (CIOCC) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre (H12O) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Instituto Valenciano de Oncología (IVO) Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| Hôpital Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Institut Claudius Regaud - iUCT Oncopole Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| CHA University - Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Sevrance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| MD Anderson Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University Health Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Rockefeller Cancer Institute Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center - Herbert Irving Pavilion Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stephenson Cancer Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Orlando Health Cancer Institute Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| LifeSpan - Brown University Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Honor Health Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Swedish Cancer Institute Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.