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

Study Identifier:
CGT6297-25-101
CT.gov Identifier:
NCT07383506
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study 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

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Breast Cancers
Bowel (Colorectal)
Ovarian
Head & Neck
Solid Tumor
Endometrial
Cervical cancer
Fallopian Tube
Vaginal
Vulvar
Primary Peritoneal
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Dose Escalation
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Drug: Part 1a: Dose Escalation of Multiple doses of CGT6297 for oral administration
Drug: Drug: CGT6297
Drug: CGT6297 Daily Oral Administration
Drug: EXPERIMENTAL: Signal Seeking
Drug: Phase 1b: Participants will receive CGT6297 at a dose level selected based on data from Phase 1a
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • 1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and/or tumor:
  • 1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer
  • 2. 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)
  • 3. 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
  • 2. Meet prior treatment requirement of:
  • 1. Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
  • 2. Phase 1b: previously treated with or considered not appropriate for SOC first-line treatment for their condition
  • 3. Have at least one measurable lesion according to RECIST v1.1.
  • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
  • 5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
  • 6. 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.
  • 7. Have an ejection fraction ≥50%
Exclusion criteria
  • 1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
  • 2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
  • 3. Treatment with radiotherapy ≤2 weeks before the first dose of study drug.
  • 4. Clinically significant cardiac disease
  • 5. 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)
  • 6. 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)
  • 7. 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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Bruno Fang
Status
Will Be Recruiting
Condition(s) Treated at Site
Breast Cancers
Bowel (Colorectal)
Ovarian
Head & Neck
Solid Tumor
Endometrial
Cervical cancer
Fallopian Tube
Vaginal
Vulvar
Primary Peritoneal
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Will Be Recruiting
Condition(s) Treated at Site
Breast Cancers
Bowel (Colorectal)
Ovarian
Head & Neck
Solid Tumor
Endometrial
Cervical cancer
Fallopian Tube
Vaginal
Vulvar
Primary Peritoneal
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
Jose Pacheco
Status
Will Be Recruiting
Condition(s) Treated at Site
Breast Cancers
Bowel (Colorectal)
Ovarian
Head & Neck
Solid Tumor
Endometrial
Cervical cancer
Fallopian Tube
Vaginal
Vulvar
Primary Peritoneal