Clinical Research Directory

Inclusion Criteria: * 18 years of age or older * Advanced or metastatic cancer of the breast or colon Part 1A, 1B, and 1C: HR+/HER2- advanced or metastatic breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and cyclin-dependent kinase (CDK)4/6 inhibitor in the advanced or metastatic setting and received no more than 1 line of prior cytotoxic and/or 1 line of prior antibody-drug conjugate (ADC) therapy in the metastatic setting Part 1D: Metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 2A: HR+/HER2- advanced or metastatic breast cancer with no prior systemic therapy or chemotherapy for advanced or metastatic disease * Phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) mutation * Archived tumor specimen or fresh tumor biopsy * Measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: * Active or clinically significant dermatologic conditions * Active malignancy within 3 years prior to enrollment * Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term * Major surgery or radiation therapy within 3 weeks prior to study entry * Prior irradiation to \>25% of the bone marrow * Active or history of pneumonitis/interstitial lung disease requiring corticosteroids * Unmanageable ascites * Prior treatment with phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mechanistic target of rapamycin (mTOR) pathway inhibitors may be permitted in certain study cohorts and excluded in others, as specified by the study protocol. * Renal impairment * Hepatic dysfunction * Hematologic abnormalities * Uncontrolled diabetes * Cardiac abnormalities * Active or history of clinically significant gastrointestinal (GI) or inflammatory GI disease * Other unacceptable abnormalities or prohibited therapies as defined by protocol