An Open Label, Multicenter Study to Evaluate the Safety, ...

Inclusion Criteria:

Archival Tissue sample for testing

Part 1A - Participants with advanced or metastatic cancer who have progressed on/after standard of care therapy or are intolerant to additional effective therapies.
Female participants with 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 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)

Clinical Trial Details