Clinical Trial

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors

Recruiting Phase 1
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Summary
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.
Protocol Amendment History 2 changes
critical Phase changed: Phase 1/2 -> Phase 1 2026-06-17
notable Trial sites expanded: 6 -> 10 locations 2026-05-21
Trial Details
NCT Number NCT07540572
Lead Sponsor IDEAYA Biosciences
Conditions ER+, HER 2- Breast Cancer, Non-small Cell Lung Cancer (NSCLC), Castration-resistant Prostate Cancer (CRPC), Microsatellite Stable (MSS) Colorectal Carcinoma
Enrollment 160 participants
Start Date 2026-03-17
Primary Completion 2030-03-30 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-16