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

Part of paid clinical trials in East Brunswick, New Jersey.

Sponsor
IDEAYA Biosciences
Study ID
NCT07540572
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Castration-resistant Prostate Cancer (CRPC)
  • ER+, HER 2- Breast Cancer
  • Microsatellite Stable (MSS) Colorectal Carcinoma
  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • IDE574 — DRUG
    IDE574
  • Fulvestrant injection — DRUG
    Fulvestrant Injection

Study Details

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.

Key Dates

Start date
Mar 17, 2026
Status verified
May 2026
Primary completion
Mar 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Dose Escalation (Part 1A)
    Participants with the appropriate tumor types will be treated with escalating doses of IDE574
  • Experimental: Monotherapy Dose Expansion (Part 1B)
    Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen monotherapy dose(s) of IDE574
  • Experimental: Combination Dose Escalation (Part 2A) IDE574 + Fulvestrant
    Participants with ER+ HER2- advanced or metastatic breast cancer will be treated with escalating doses of IDE574 in combination with fulvestrant
  • Experimental: Combination Dose Expansion (Part 2B)
    Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen combination dose(s) of IDE574 + Fulvestrant

Primary Outcome Measure

Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation [ Time Frame: 21 days following the first dose of IDE574 ]

Locations (10)

FacilityCityStateZIPSite coordinators
START Astera, LLCEast BrunswickNew Jersey08816
Bruno S Fang
[email protected]
732-426-4750
START New York Long Island, LLCLake SuccessNew York11042
Geralinde O'Sullivan Coyne
[email protected]
363-207-5160
NEXT Texas LLC - AustinAustinTexas78758
Sheena Sahota
[email protected]
737-610-5200
NEXT Texas LLC - DallasDallasTexas75039
Farah Polani
[email protected]
972-893-8800
START Dallas Fort Worth, LLCFort WorthTexas76104
Henry Xiong
[email protected]
682-350-3010
NEXT Texas LLC - HoustonHoustonTexas77054
Jennifer Segar
[email protected]
832-384-7900
NEXT Texas LLC - San AntonioSan AntonioTexas78229
David Sommerhalder
[email protected]
210-580-9500
Start San Antonio, LLCSan AntonioTexas78229
Amita Patnaik
[email protected]
2105935250
START Mountain Region, LLCWest Valley CityUtah84119
William B McKean
[email protected]
1 (801) 907-4750
NEXT VirginiaFairfaxVirginia22031
Mohamad A Salkeni
[email protected]
703-783-4510

Find similar trials in East Brunswick, NJ

By research site
START Astera, LLC· East Brunswick, NJSTART New York Long Island, LLC· Lake Success, NYNEXT Texas LLC - Austin· Austin, TXNEXT Texas LLC - Dallas· Dallas, TXSTART Dallas Fort Worth, LLC· Fort Worth, TXNEXT Texas LLC - Houston· Houston, TX

Related Studies