A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This early study tests CGT6297 in adults with advanced solid tumors that have changes in a gene called PIK3CA. It looks at the drug’s safety, side effects, how the body handles it, and how it affects the body and cancer.
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
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have an advanced solid tumor confirmed by tissue testing, with a cancer-driving PIK3CA gene change found in blood or tumor tests.
- For Phase 1b, join a group based on cancer type: endometrial cancer (cancer of the womb lining); breast cancer that is hormone receptor-positive and HER2-negative or HER2-low; or another solid tumor. Breast cancer tests must meet study standards.
- For Phase 1a, past treatments must have stopped working or caused side effects you could not tolerate. For Phase 1b, you must have had standard first treatment, or it must not be right for you.
- Have at least one tumor that can be measured using the study’s rules.
- Be fully active or able to do light work despite limits on hard physical activity.
- Have blood test results within the study’s allowed limits.
- Side effects from past cancer treatment, including important abnormal lab results, must have returned to mild levels or your usual level, with some study-specific exceptions.
- Have a heart pumping measure called ejection fraction of at least 50%.
Who can't join
- Had certain cancer drugs or radiation too close to the first study dose. Radiation within 2 weeks is not allowed.
- Had major surgery within 4 weeks before the first study dose.
- Have significant heart disease.
- Take or plan to take steroid medicines for at least 4 weeks in a row at a dose greater than the equivalent of 20 mg of prednisone per day.
- Have type 1 diabetes or uncontrolled type 2 diabetes. The study defines uncontrolled as fasting blood sugar of at least 140 mg/dL and HbA1c (a measure of average blood sugar) of at least 7%. Diabetes medicines other than insulin are allowed.
- Past tumor gene tests found changes or missing parts in PTEN, or activating changes in AKT, HRAS, KRAS, NRAS, EGFR, or BRAF.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (11)
AZ
- HonorHealth Research Institute · Scottsdale, AZ 85258More trials in Scottsdale
CA
- START Los Angeles · Los Angeles, CA 90025More trials in Los Angeles
CO
- Sarah Cannon Research Institute (SCRI) at HealthONE-Denver · Denver, CO 80218More trials in Denver
FL
- H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. · Tampa, FL 33612More trials in Tampa
MA
- Dana-Farber Cancer Institute · Boston, MA 02215More trials in Boston
MO
- Washington University School of Medicine - Siteman Cancer Center · St Louis, MO 63110More trials in St Louis
NJ
- START New Jersey, LLC · East Brunswick, NJ 08816More trials in East Brunswick
TN
- SCRI Oncology Partners - Nashville · Nashville, TN 01071More trials in Nashville
TX
- NEXT Austin · Austin, TX 78758More trials in Austin
UT
- START Mountain Region, LLC · West Valley City, UT 84119More trials in West Valley City
VA
- NEXT Virginia · Fairfax, VA 22031More trials in Fairfax