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

Trial Details

NCT ID
NCT07383506
Phase
PHASE1
Sponsor
Cogent Biosciences, Inc.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • CGT6297
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Los Angeles, California, United States|34.05223,-118.24368
  • Denver, Colorado, United States|39.73915,-104.9847
  • Tampa, Florida, United States|27.94752,-82.45843
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and/or tumor:
  • Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer
  • Phase 1b Cohort 2, participants must have HR-positive/HER2-negative or HER2-low breast cancer (immunohistochemistry \[IHC\] and in-situ hybridizati…
  • 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, other gynecol…

For full eligibility, visit ClinicalTrials.gov.

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