BridgeMD
New treatment option for PIK3CA Mutations
Official title A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07383506
What this study is testing
What is CGT6297?
CGT6297 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pik3ca mutations.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Meet prior treatment requirement of:
You likely can't join if
- 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...
- Diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 (defined as fasting glucose ≥140 mg/dL and HbA1c ≥7.0%...
See the full 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 hybridization results must meet ASCO-College of American Pathology guidelines for...
- 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...
- Have an ejection fraction ≥50%
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- St Louis, Missouri, United States
- Austin, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; St Louis, Missouri, United States; Austin, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.