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Tests treatment safety and results for ER+, HER 2- Breast Cancer
Official title A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07540572
What this study is testing
What is IDE574?
IDE574 is an investigational medicine, being studied as a potential treatment for er+, her 2- breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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...
- 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...
- Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to...
- Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Plantation, Florida, United States
- East Brunswick, New Jersey, United States
- Lake Success, New York, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Plantation, Florida, United States; East Brunswick, New Jersey, United States; Lake Success, New York, United States; Austin, Texas, United States; Dallas, Texas, United States; Fort Worth, Texas, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.