This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer. Participants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.
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Incidence of dose limiting toxicities (DLTs)
Timeframe: 4 weeks (1 cycle)
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Every cycle (4-week cycles) until study discontinuation, approximately 12 months