NCT07383506 · Cogent Biosciences, Inc.
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
What this study is about
This is a Phase 1, two-part, where both patients and doctors know the treatment given, nonrandomized, gradually increasing doses and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, how the drug affects the body (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations
View original scientific description
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
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) and AEs leading to dose modifications and dose limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) or the maximum evaluated dose (MED) of CGT6297 in participants with advanced solid tumors harboring PIK3CA mutations
Overall Response Rate [Phase 1b]
Time frame: Approximately 8 months
Overall Response Rate (ORR), as determined by CR + PR based on Investigator assessment using RECIST v1.1
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Scottsdale, Arizona
- Los Angeles, California
- Denver, Colorado
- Tampa, Florida
- Boston, Massachusetts
- St Louis, Missouri
- East Brunswick, New Jersey
- Nashville, Tennessee
- Austin, Texas
- West Valley City, Utah
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2026 · Source of record for eligibility and locations