A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations
Cogent Biosciences, Inc.
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and/or tumor: 1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer 2. 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) 3. 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, othe…
Interventions
- DrugCGT6297
CGT6297 Daily Oral Administration
Locations (2)
- NEXT AustinAustin, Texas
- NEXT VirginiaFairfax, Virginia