A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy i… (NCT07540572) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
United States160 participantsStarted 2026-03-17
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
Archival Tissue sample for testing
* Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on/after at least one line of standard of care therapy or are intolerant to additional effective therapies.
* Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4/6 inhibitor
* Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only)
* Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age \<60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries
* Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1.
* Have adequate bone marrow, renal and liver function.
* Life expectancy of \>3 months
* Able to safely administer and retain orally administered study treatment
* Able to comply with contraceptive/barrier requirements
Key Exclusion Criteria:
* Known symptomatic brain metastases or leptomeningeal metastasis
* Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor.
* Have impairm…
What they're measuring
1
Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation
Timeframe: 21 days following the first dose of IDE574
2
Safety and Tolerability of IDE574 in Part 1B Monotherapy Dose expansion based on incidence and severity of AEs/SAEs
Timeframe: Approximately 24 months total study duration
3
To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on the ORR per RECIST version 1.1
Timeframe: Approximately 24 months total study duration
4
To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on DOR per RECIST version 1.1.
Timeframe: Approximately 24 months total study duration
5
Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2A Combination Dose Escalation based on incidence of DLT
Timeframe: Approximately 24 months total study duration
6
Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the incidence and severity of AEs/SAEs
Timeframe: Approximately 24 months total study duration
7
Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the ORR per RECIST version 1.1