IDE574 for adults with advanced solid tumors: safety and early activity
An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer
We will try IDE574 alone or with fulvestrant to see if it is safe and shows early benefit for adults with advanced ER+, HER2- breast cancer and several other solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | IDEAYA Biosciences Industry-sponsored |
| Locations | 6 sites (Lake Success, New York and 5 other locations) |
| Trial ID | NCT07540572 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 study uses a dose-escalation then expansion design to test IDE574 as a single agent and in combination with fulvestrant for ER+, HER2- breast cancer. Part 1A escalates IDE574 doses to find dose-limiting toxicities, a maximum tolerated dose or a recommended dose for expansion, with Part 1B expanding selected cohorts including an ER+ breast cancer expansion and optional basket cohorts for other tumor types. Part 2 repeats dose escalation and expansion of IDE574 given with fulvestrant specifically in ER+, HER2- breast cancer. The trial includes PK and PD sampling, requires archival tumor tissue, and enrolls patients who have progressed after prior standard therapies.
Who should consider this trial
Good fit: Ideal candidates are adults with locally advanced or metastatic ER+, HER2- breast cancer (for combination and expansion cohorts) or adults with advanced/metastatic NSCLC, CRPC, or MSS colorectal cancer who have progressed after at least one standard therapy and can provide archival tumor tissue.
Not a fit: Patients who are untreated, have poor performance status, cannot provide required tissue, or have tumor types not included in the cohorts are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, IDE574 could provide a new targeted oral option that slows or stops growth in tumors driven by KAT6/KAT7 activity, especially in ER+, HER2- breast cancer.
How similar studies have performed: Targeting KAT6/KAT7 is a relatively novel approach with encouraging preclinical data but limited published clinical results to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 impairment of GI function or GI disease that may significantly alter the absorption of IDE574. * Have active liver or biliary disease. * Have active, uncontrolled bacterial, fungal, or viral infection * Have clinically significant cardiac abnormalities and/or blood clotting events within 6 months before the first dose * If participants had adverse reactions to previous experimental antitumor treatment that have not recovered to Grade ≤ 1 * Prior irradiation to \>25% of the bone marrow. * Known or suspected hypersensitivity to IDE574/excipients or components (Parts 1 \& 2) or fulvestrant/excipients or components (Part 2 only)
Where this trial is running
Lake Success, New York and 5 other locations
- Start Ny — Lake Success, New York, United States (Active_not_recruiting)
- NEXT Texas LLC - Austin — Austin, Texas, United States (Recruiting)
- NEXT Texas LLC - Dallas — Dallas, Texas, United States (Recruiting)
- NEXT Texas LLC - Houston — Houston, Texas, United States (Recruiting)
- NEXT Texas LLC - San Antonio — San Antonio, Texas, United States (Recruiting)
- Start San Antonio, LLC — San Antonio, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.