Trials / Not Yet Recruiting
Not Yet RecruitingNCT07383506
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Cogent Biosciences, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- PIK3CA Mutations
- Advanced Solid Tumors, Adult
- Endometrial Cancer
- HR Positive/HER-2 Negative Breast Cancer
- HER2-low Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CGT6297 | CGT6297 Daily Oral Administration |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2029-07-01
- Completion
- 2029-08-01
- First posted
- 2026-02-03
- Last updated
- 2026-03-27
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07383506. Inclusion in this directory is not an endorsement.