A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors

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

NCT Number	NCT07383506
Lead Sponsor	Cogent Biosciences, Inc.
Conditions	PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2-low Breast Cancer
Enrollment	90 participants
Start Date	2026-06
Primary Completion	2029-07 (estimated)
Study Completion	2029-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-01