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Phase 1 Study of CGT6297 for Advanced Solid Tumors with PIK3CA Mutations

This study is testing a drug called CGT6297 in adults with advanced solid tumors that have specific changes (mutations) in a gene called PIK3CA. This includes certain types of endometrial cancer and breast cancer (HR-positive/HER2-negative or HER2-low). Researchers want to see how safe CGT6297 is, what side effects it causes, and if it can shrink tumors. The study will measure how many participants experience side effects over about 12 months, and how many see their tumors shrink over about 8 months. The study plans to enroll 90 participants, but its current status is unclear.

Study design
This is a Phase 1, open-label study, meaning you and your doctors will know which treatment you are receiving. It is designed to test different doses of CGT6297 and look for signs of effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure side effects for approximately 12 months and tumor response for approximately 8 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07383506

A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Cogent Biosciences, Inc.
~90 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:CGT6297

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a]
Measured over Approximately 12 months
+1 more outcome measured

Conditions

PIK3CA Mutations
Advanced Solid Tumors, Adult
Endometrial Cancer
HR Positive/HER-2 Negative Breast Cancer
HER2-low Breast Cancer

Explore related trials

Breast CarcinomaEndometrial CarcinomaSolid NeoplasmPIK3CA Gene

Where it's being run

11 sites across 11 states
Arizona1
California1
Colorado1
Florida1
Massachusetts1
Missouri1
New Jersey1
Tennessee1

Who to contact

Cogent Biosciences, Inc
[email protected]
6179455576
Email the study team

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What this trial measures

  • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Phase 1a]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]Approximately 8 months

    Overall Response Rate (ORR), as determined by CR + PR based on Investigator assessment using RECIST v1.1