A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
NCT07540572 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-05-20
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.
Conditions
- ER+, HER 2- Breast Cancer
- Non-small Cell Lung Cancer (NSCLC)
- Castration-resistant Prostate Cancer (CRPC)
- Microsatellite Stable (MSS) Colorectal Carcinoma
Interventions
- DRUG
-
IDE574
IDE574
- DRUG
-
Fulvestrant injection
Fulvestrant Injection
Sponsors & Collaborators
-
IDEAYA Biosciences
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-17
- Primary Completion
- 2030-03-30
- Completion
- 2030-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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