Actively Recruiting
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Led by IDEAYA Biosciences · Updated on 2026-04-20
160
Participants Needed
6
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Archival tissue sample available for testing
- Adults with advanced or metastatic ER+, HER2- breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, or microsatellite stable colorectal adenocarcinoma who progressed after at least one standard therapy or cannot tolerate further effective therapies
- For Parts 1B, 2A, and 2B: Participants with ER+, HER2- breast cancer who progressed after at least one prior line of endocrine therapy and a CDK4/6 inhibitor
- Female participants with ER+, HER2- breast cancer who are of childbearing potential must be willing to undergo medically induced menopause (Parts 2A and 2B)
- Female participants of nonchildbearing potential must be age 60 or older, or under 60 with no menstruation for at least 12 months, or have had both ovaries removed
- Eastern Cooperative Oncology Group performance status of 1 or less
- Adequate bone marrow, kidney, and liver function
- Life expectancy greater than 3 months
- Able to safely take and keep oral study treatment
- Able to follow contraceptive or barrier method requirements
You will not qualify if you...
- Known symptomatic brain metastases or leptomeningeal metastasis
- Known primary central nervous system malignancy or other malignancies within 2 years before first dose, except adequately treated localized tumors
- Gastrointestinal issues that could significantly affect IDE574 absorption
- Active liver or biliary disease
- Active, uncontrolled bacterial, fungal, or viral infection
- Significant heart problems or blood clotting events within 6 months before first dose
- Unresolved adverse reactions from previous experimental cancer treatments above Grade 1
- Prior radiation to more than 25% of bone marrow
- Known or suspected allergy to IDE574 or fulvestrant or their ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
START NY
Lake Success, New York, United States, 11042
Active, Not Recruiting
2
NEXT Texas LLC - Austin
Austin, Texas, United States, 78758
Actively Recruiting
3
NEXT Texas LLC - Dallas
Dallas, Texas, United States, 75039
Actively Recruiting
4
NEXT Texas LLC - Houston
Houston, Texas, United States, 77054
Actively Recruiting
5
NEXT Texas LLC - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
6
Start San Antonio, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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