A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
Start Date
3/17/2026
Completion Date
6/30/2030
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.
Detailed Description
Part 1 - Monotherapy Dose Escalation and Expansion: Part 1A - Monotherapy Dose Escalation Part 1A will evaluate increasing doses of IDE574 to assess safety, tolerability and to determine dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) or the recommended dose for expansion (RDE) in subjects with advanced or metastatic ER+, HER2- breast cancer, non-small cell lung cancer, castration-resistant prostate cancer and microsatellite-stable colorectal cancer. Part 1B - Monotherapy Dose Expansion Part 1B will evaluate in ER+ HER2- advanced or metastatic breast cancer at the potential dose level(s) determined to be safe and tolerable during monotherapy dose escalation Part 1A. In parallel, a basket cohort may be enrolled at or below the highest safe dose level(s) determined to be safe and tolerable in Part 1A. Part 2 - Combination Dose Escalation and Expansion Part 2A - IDE574 Combination Therapy with Fulvestrant Dose Escalation Part 2A will evaluate participants with ER+ HER2- advanced or metastatic breast cancer with escalating doses of IDE574 in combination with fulvestrant to assess safety, tolerability and to determine DLTs, MTD or RDE. Part 2B - IDE574 Combination Therapy with Fulvestrant Dose Expansion Part 2B will be evaluated in ER+ HER2- advanced or metastatic breast cancer at the potential dose level(s) determined to be safe and tolerable during combination dose escalation Part 2A.
Eligibility Criteria
Age Range: 18 years to 99 years
Interventions
IDE574
Fulvestrant injection
Conditions
Locations
Florida Clinical Trials Group
Plantation, Florida 33322
United States
START Astera, LLC
East Brunswick, New Jersey 08816
United States
START New York Long Island, LLC
Lake Success, New York 11042
United States
NEXT Texas LLC - Austin
Austin, Texas 78758
United States
NEXT Texas LLC - Dallas
Dallas, Texas 75039
United States
START Dallas Fort Worth, LLC
Fort Worth, Texas 76104
United States
NEXT Texas LLC - Houston
Houston, Texas 77054
United States
NEXT Texas LLC - San Antonio
San Antonio, Texas 78229
United States
Start San Antonio, LLC
San Antonio, Texas 78229
United States
START Mountain Region, LLC
West Valley City, Utah 84119
United States
NEXT Virginia
Fairfax, Virginia 22031
United States