PIK3CA MutationsPhase 1NCT07383506
A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors
A Phase 1 study testing CGT6297 in people with PIK3CA Mutations and Advanced Solid Tumors, Adult, run by Cogent Biosciences, Inc. at 12 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer
- What is being tested?
- CGT6297
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 12 sitesUnited States
- Study dates
- 23 Jul 2026to Aug 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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%
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
NEXT Austin
Austin, Texas, 78758
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Sarah Cannon Research Institute (SCRI) at HealthONE-Denver
Denver, Colorado, 80218
- Recruiting
START New Jersey, LLC
East Brunswick, New Jersey, 08816
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
START Los Angeles
Los Angeles, California, 90025
- Recruiting
SCRI Oncology Partners - Nashville
Nashville, Tennessee, 01071
- Recruiting
Stanford Cancer Center
Palo Alto, California, 94304
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
- Recruiting
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
- Recruiting
H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.
Tampa, Florida, 33612
- Recruiting
START Mountain Region, LLC
West Valley City, Utah, 84119
About this study
Official title: A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations
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
- Conditions
- PIK3CA Mutations, Advanced Solid Tumors, Adult, Endometrial Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2-low Breast Cancer
- Being tested
- CGT6297
- Keywords
- HER2, PI3K, Mutant-Selective Inhibitor, Advanced solid tumors, PIK3CA Mutations, PIK3CA SNVs, Endometrial Cancer, Breast Cancer, HR+/HER2 Negative breast cancer, HR+/HER2 (-) breast cancer, HR+/HER2 low breast cancer, PI3KCA Genetic Alterations, PI3KCA Point Mutations, PI3KCA Gene Short Variants, PI3KCA active alteration, HER2-low Breast Cancer, Phase 1a/1b
- Medical subject headings
- Endometrial Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGT6297Drug
CGT6297 Daily Oral Administration
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Part 1a: Dose Escalation of Multiple doses of CGT6297 for oral administration Receives: Drug: CGT6297 |
| Signal Seeking | Experimental | Phase 1b: Participants will receive CGT6297 at a dose level selected based on data from Phase 1a Receives: Drug: CGT6297 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a]
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
Measured: Approximately 12 months
Overall Response Rate [Phase 1b]
Overall Response Rate (ORR), as determined by CR + PR based on Investigator assessment using RECIST v1.1
Measured: Approximately 8 months
Secondary outcomes (7)
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1b]
- Incidence and grade of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs leading to dose modification
- Changes from baseline in key laboratory results and electrocardiogram (ECG) parameters
Measured: Approximately 12 months
Pharmacokinetics (Part 1a)
Area under the concentration-time curve (AUC) in participants with advanced solid tumors harboring PI3K mutations
Measured: Approximately 28 days
Pharmacokinetics (Part 1a)
Maximum observed concentration (Cmax) in participants with advanced solid tumors harboring PI3K mutations
Measured: Approximately 28 days
Pharmacokinetics (Part 1a)
Observed concentration at predose (Ctrough) in participants with advanced solid tumors harboring PI3K mutations
Measured: Approximately 28 days
Pharmacokinetics (Part 1a)
Time to maximum concentration (Tmax) in participants with advanced solid tumors harboring PI3K mutations
Measured: Approximately 28 days
Disease Response (Part 1b)
Objective response rate (ORR), determined by confirmed (CR) + (PR) based on Investigator assessment using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Measured: Approximately 8 months
Disease Response (Part 1b)
Disease control rate (DCR), as determined by confirmed CR + PR + stable disease (SD) based on Investigator assessment using RECIST v1.1
Measured: Approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start23 Jul 2026
- Primary completionJul 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PIK3CA MutationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1, Part A evaluating multiple ascending doses Phase 1b, evaluation of Part A selected doses in 3 cohorts defined by tumor type including a randomized dose optimization design (Part B)
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cogent Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383506
- Sponsor's protocol ID
- CGT6297-25-101
- Status last verified
- Oct 2026
- First submitted
- 26 Jan 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No