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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 4 → 11 locations
    • Start date changed from estimate of Jun 2026 to Jul 23, 2026
    v5
  2. Minor Study sites: 2 to 4v4
  3. Notable Recruitment opened
    • Start date: Feb 2026 to Jun 2026
    • Site details revised at 2 of 2 sites
    v3
  4. Minor Study sites: 0 to 2v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07383506
Lead Sponsor Cogent Biosciences, Inc.
Conditions
(from sponsor)
PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2-low Breast Cancer
Related terms Breast Neoplasms, Endometrial Neoplasms
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov