NCT07540572RecruitingPhase 1
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
IDE574 is a synthetically manufactured small molecule inhibitor that co-targets the lysine acetyltransferase enzymes KAT6 and KAT7. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IDE574 as monotherapy in participants with locally advanced or metastatic solid tumors and as combination therapy with fulvestrant in participants with advanced or metastatic ER+, HER2- breast cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- 17 Mar 2026
- Primary completion date
- 30 Mar 2030
- Lead sponsor
- IDEAYA Biosciences
- Diseases
- Prostate cancer, Lung cancer, Colorectal cancer
- NCT number
- NCT07540572
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 160
- From 17 Mar 2026 to the primary completion date, 30 Mar 2030
- 11 sites in 1 country
- 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
- Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor.
- Have clinically significant cardiac abnormalities and/or blood clotting events within 6 months before the first dose
- If participants had adverse reactions to previous experimental antitumor treatment that have not recovered to Grade ≤ 1
- Prior irradiation to \>25% of the bone marrow.
Other illness
- Have impairment of GI function or GI disease that may significantly alter the absorption of IDE574.
- Have active liver or biliary disease.
- Have active, uncontrolled bacterial, fungal, or viral infection
- Known or suspected hypersensitivity to IDE574/excipients or components (Parts 1 \& 2) or fulvestrant/excipients or components (Part 2 only)
Other
- Known symptomatic brain metastases or leptomeningeal metastasis
Who the study is looking for
- Archival Tissue sample for testing
- Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on/after at least one line of standard of care therapy or are intolerant to additional effective therapies.
- Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4/6 inhibitor
- Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only)
- Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age \<60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries
- Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1.
- Have adequate bone marrow, renal and liver function.
- Life expectancy of \>3 months
- Able to safely administer and retain orally administered study treatment
- Able to comply with contraceptive/barrier requirements
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NEXT Texas LLC - Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| NEXT Texas LLC - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| START Astera, LLC Coordinator of this site? Confirm its status | East Brunswick | United States | Recruiting |
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| START Dallas Fort Worth, LLC Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| NEXT Texas LLC - Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| START New York Long Island, LLC Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| Florida Clinical Trials Group. Coordinator of this site? Confirm its status | Plantation | United States | Recruiting |
| Start San Antonio, LLC Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| NEXT Texas LLC - San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| START Mountain Region, LLC Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.