🏛️ Verified NIH Record • Updated 2026-08-24

A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors (NCT07383506)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Cogent Biosciences, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (8 items).

Location: HonorHealth Research Institute — Scottsdale, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
  • Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
  • Treatment with radiotherapy ≤2 weeks before the first dose of study drug.
  • Clinically significant cardiac disease
  • Ongoing or planned long-term (≥4 consecutive weeks) treatment with glucocorticoid steroids at greater than physiologic dosing (defined as equivalent to \>20 mg/day prednisone)
  • Diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 (defined as fasting glucose ≥140 mg/dL and HbA1c ≥7.0%; antihyperglycemic medical management permitted with the exception of insulin)
  • Previous molecular testing (NGS or PCR) showed tumor with the following mutations: mutations/deletions in PTEN or activating mutations in AKT, HRAS/KRAS/NRAS, EGFR, and BRAF

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

  • HonorHealth Research Institute — Scottsdale, Arizona
  • START Los Angeles — Los Angeles, California
  • Sarah Cannon Research Institute (SCRI) at HealthONE-Denver — Denver, Colorado
  • H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. — Tampa, Florida
  • Dana-Farber Cancer Institute — Boston, Massachusetts
  • Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri
  • START New Jersey, LLC — East Brunswick, New Jersey
  • SCRI Oncology Partners - Nashville — Nashville, Tennessee
  • NEXT Austin — Austin, Texas
  • START Mountain Region, LLC — West Valley City, Utah
  • NEXT Virginia — Fairfax, Virginia

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗