This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations
Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer
Phase 1b Cohort 2, participants must have HR-positive/HER2-negative or HER2-low breast cancer (immunohistochemistry [IHC] and in-situ hybridization results must meet ASCO-College of American Pathology guidelines for breast cancer or criteria)
Phase 1b Cohort 3 will allow all solid tumors that do not meet criteria for Phase 1b Cohorts 1 or 2, including head and neck cancers, other gynecological cancers, colorectal cancers harboring PIK3CA mutations
Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
Treatment with radiotherapy ≤2 weeks before the first dose of study drug.
Clinically significant cardiac disease