Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CGT4859 · 1 trial · 12 indications
Incidence, severity, and seriousness or treatment-emergent adverse events (AEs) leading to dose modification
Clinically significant changes or abnormalities observed from baseline in laboratory results in chemistry, hematology, and coagulation parameters
Clinically significant changes or abnormalities observed from baseline in electrocardiogram (ECG) parameters
| Arm | Type | Description |
|---|---|---|
| Phase 1: Dose Escalation | EXPERIMENTAL | Multiple doses of CGT4859 for oral administration |
| Phase 2: Signal Seeking | EXPERIMENTAL | Oral dose of CGT4859 at the RP2D as determined in Phase 1 |
| Name | Type | Description |
|---|---|---|
| CGT4859 | DRUG | CGT4859 is a selective FGFR2/3 inhibitor |
Key Inclusion Criteria: 1. Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor. 2. Previously treated with, not appropriate for, or declined standard-of-care first-line treatment. 3. Have measu...
CGT4859 is an investigational small molecule FGFR2/3 inhibitor being developed by Cogent Biosciences, Inc. for intrahepatic cholangiocarcinoma and other advanced solid tumors with FGFR2 or FGFR3 genetic alterations. It is currently in Phase 1 clinical development and has not been approved by the FDA.
CGT4859 is being studied for the treatment of intrahepatic cholangiocarcinoma, a cancer of the bile ducts within the liver, in patients whose tumors carry FGFR2 genetic alterations such as gene fusions, rearrangements, amplifications, or short variants. It is investigational and has not been approved for any indication.
CGT4859 targets FGFR2 and FGFR3, members of the fibroblast growth factor receptor (FGFR) family of receptor tyrosine kinases. The drug is designed to inhibit these receptors in tumors driven by FGFR2 or FGFR3 genetic alterations, including gene fusions, rearrangements, amplifications, and short variants.
CGT4859 is being developed by Cogent Biosciences, Inc., a biotechnology company that trades on the Nasdaq under the ticker symbol COGT. Cogent Biosciences is the sponsor of the ongoing Phase 1 clinical trial evaluating CGT4859 in cholangiocarcinoma and other advanced solid tumors.
CGT4859 is in Phase 1 clinical development. It is an investigational agent and has not received FDA approval. The single ongoing Phase 1 trial is currently active but not recruiting, with a planned enrollment of 110 participants across sites in the United States and Canada.
CGT4859 is being evaluated in one Phase 1 clinical trial, NCT06777316, titled A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors. The trial is active but not recruiting, has a planned enrollment of 110 adults, and is being conducted in the United States and Canada.