Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CGT6297 · 1 trial · 5 indications
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 (ORR), as determined by CR + PR based on Investigator assessment using RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Part 1a: Dose Escalation of Multiple doses of CGT6297 for oral administration |
| Signal Seeking | EXPERIMENTAL | Phase 1b: Participants will receive CGT6297 at a dose level selected based on data from Phase 1a |
| Name | Type | Description |
|---|---|---|
| CGT6297 | DRUG | CGT6297 Daily Oral Administration |
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 ca...
CGT6297 is an investigational small molecule developed by Cogent Biosciences, Inc. for PIK3CA-mutated cancers. It is being studied in adults with advanced solid tumors, including endometrial cancer and HR positive/HER-2 negative or HER2-low breast cancer. It is a Phase 1, biomarker-selected therapy and has not been approved by the FDA.
CGT6297 is being evaluated for the treatment of advanced solid tumors that carry PIK3CA mutations. The Phase 1 study enrolls adults with PIK3CA-mutant cancers, including endometrial cancer, HR positive/HER-2 negative breast cancer, and HER2-low breast cancer. It is investigational and its safety and efficacy have not been established.
CGT6297 targets PI3K, a kinase enzyme. It is described as a mutant-selective inhibitor, meaning it is designed to act on the PI3K pathway in tumors carrying PIK3CA mutations. This targeted approach is why the trial selects patients based on PIK3CA mutation status rather than enrolling an unselected population.
CGT6297 is being developed by Cogent Biosciences, Inc., which trades on the Nasdaq under the ticker COGT. The company is running the Phase 1 study of the compound in patients with PIK3CA-mutant advanced solid tumors. Cogent Biosciences is the sponsor responsible for the clinical program.
CGT6297 is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The single registered trial is a Phase 1 study that is currently recruiting participants, with an planned enrollment of 90 patients. No trials of CGT6297 have been completed.
CGT6297 is being studied in one clinical trial, NCT07383506, titled A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors. The Phase 1 trial is recruiting in the United States, plans to enroll 90 adults aged 18 and older, and includes a controlled design without randomization or blinding.