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
Sequential
CGT6297
DrugCGT6297 Daily Oral Administration
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a]
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) and AEs leading to dose modifications and dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) or the maximum evaluated dose (MED) of CGT6297 in participants with advanced solid tumors harboring PIK3CA mutations
Overall Response Rate [Phase 1b]
Overall Response Rate (ORR), as determined by CR + PR based on Investigator assessment using RECIST v1.1
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1b]
* Incidence and grade of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs leading to dose modification * Changes from baseline in key laboratory results and electrocardiogram (ECG) parameters
Pharmacokinetics (Part 1a)
Area under the concentration-time curve (AUC) in participants with advanced solid tumors harboring PI3K mutations
Pharmacokinetics (Part 1a)
Maximum observed concentration (Cmax) in participants with advanced solid tumors harboring PI3K mutations
Pharmacokinetics (Part 1a)
Observed concentration at predose (Ctrough) in participants with advanced solid tumors harboring PI3K mutations
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