A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations
Summary
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
Arms & interventions
- DrugCGT6297
CGT6297 Daily Oral Administration
Outcome measures
Primary
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
Secondary
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1b]
Time frame: Approximately 12 months
Pharmacokinetics (Part 1a)
Time frame: Approximately 28 days
Pharmacokinetics (Part 1a)
Time frame: Approximately 28 days
Pharmacokinetics (Part 1a)
Time frame: Approximately 28 days
Pharmacokinetics (Part 1a)
Time frame: Approximately 28 days
Disease Response (Part 1b)
Time frame: Approximately 8 months
Disease Response (Part 1b)
Time frame: Approximately 28 days
Eligibility criteria
Study locations (2)
NEXT Austin
Austin, Texas, 78758
NEXT Virginia
Fairfax, Virginia, 22031