A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors (NCT07383506) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
United States90 participantsStarted 2026-02
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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 hybridization results must meet ASCO-College of American Pathology guidelines for breast cancer or criteria)
✓. 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 gynecological cancers, colorectal cancers harboring PIK3CA mutations
✓. Meet prior treatment requirement of:
✓. Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
✓. Phase 1b: previously treated with or considered not appropriate for SOC first-line treatment for their condition
✓. Have at least one measurable lesion according to RECIST v1.1.
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
✕
What they're measuring
1
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a]
. 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