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Recruiting NCT07383506

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

Phase I Interventional PIK3CA Mutations Advanced Solid Tumors, Adult Endometrial Cancer HR Positive/HER-2 Negative Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CGT6297.
Who it may be relevant to
Registry conditions: PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations

Overview

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

Interventions

  • Drug CGT6297
    CGT6297 Daily Oral Administration

Primary outcome measures

  • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a] [Time frame: Approximately 12 months]
  • Overall Response Rate [Phase 1b] [Time frame: Approximately 8 months]
Secondary outcome measures (7)
  • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1b] [Time frame: Approximately 12 months]
  • Pharmacokinetics (Part 1a) [Time frame: Approximately 28 days]
  • Pharmacokinetics (Part 1a) [Time frame: Approximately 28 days]
  • Pharmacokinetics (Part 1a) [Time frame: Approximately 28 days]
  • Pharmacokinetics (Part 1a) [Time frame: Approximately 28 days]
  • Disease Response (Part 1b) [Time frame: Approximately 8 months]
  • Disease Response (Part 1b) [Time frame: Approximately 28 days]

Eligibility criteria

Inclusion 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 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
  • Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
  • Resolution of acute toxicities from prior anticancer therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities (other than parameters specified in screening testing as outlined below), as determined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) v5.0.
  • Have an ejection fraction ≥50%

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • HonorHealth Research Institute — Scottsdale
  • Washington University School of Medicine - Siteman Cancer Center — St Louis
  • NEXT Austin — Austin
  • NEXT Virginia — Fairfax

Identifiers

NCT: NCT07383506 · CGT6297-25-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗