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

Korábbi kezelés

• 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 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.

Más betegség

• 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
• Known or suspected hypersensitivity to IDE574/excipients or components (Parts 1 \& 2) or fulvestrant/excipients or components (Part 2 only)

Egyéb

• Known symptomatic brain metastases or leptomeningeal metastasis

• 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