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 being developed for the treatment of advanced solid tumors with PIK3CA mutations, including endometrial cancer and HR-positive/HER2-negative or HER2-low breast cancer. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
CGT6297 targets PI3K, a kinase enzyme involved in cell growth and survival. By inhibiting this target, the drug is designed to interfere with signaling pathways that drive tumor growth in cancers harboring PIK3CA mutations.
CGT6297 is being developed by Cogent Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol COGT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
CGT6297 is in Phase 1 clinical development. It is an investigational drug currently being studied in a recruiting clinical trial for patients with advanced solid tumors and PIK3CA mutations. The drug has not yet received FDA approval and remains in early-stage testing.
CGT6297 is being evaluated in a single Phase 1 clinical trial registered as NCT07383506, titled "A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors." The trial is recruiting participants in the United States and aims to enroll approximately 90 patients.
CGT6297 is a mutant-selective PI3K inhibitor, meaning it is designed to specifically target mutated forms of PI3K. While it shares a molecular target with other PI3K inhibitors, it is a distinct investigational compound developed by Cogent Biosciences and is not the same as any approved PI3K inhibitor.