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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
CGT6297 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
Time frame: Approximately 12 months
Overall Response Rate [Phase 1b]
Overall Response Rate (ORR), as determined by CR + PR based on Investigator assessment using RECIST v1.1
Time frame: Approximately 8 months
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
Time frame: Approximately 12 months
Pharmacokinetics (Part 1a)
Area under the concentration-time curve (AUC) in participants with advanced solid tumors harboring PI3K mutations
Time frame: Approximately 28 days
Pharmacokinetics (Part 1a)
Maximum observed concentration (Cmax) in participants with advanced solid tumors harboring PI3K mutations
Time frame: Approximately 28 days
Pharmacokinetics (Part 1a)
Observed concentration at predose (Ctrough) in participants with advanced solid tumors harboring PI3K mutations
Time frame: Approximately 28 days
Pharmacokinetics (Part 1a)
Time to maximum concentration (Tmax) in participants with advanced solid tumors harboring PI3K mutations
Time frame: Approximately 28 days
Disease Response (Part 1b)
Objective response rate (ORR), determined by confirmed (CR) + (PR) based on Investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Approximately 8 months
Disease Response (Part 1b)
Disease control rate (DCR), as determined by confirmed CR + PR + stable disease (SD) based on Investigator assessment using RECIST v1.1
Time frame: Approximately 28 days
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