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 being developed for intrahepatic cholangiocarcinoma (ICC) and other advanced solid tumors. It is designed for patients with FGFR2 or FGFR3 genetic alterations, including gene fusions, rearrangements, amplifications, and short variants. The drug is currently in Phase 1 clinical development.
CGT4859 targets FGFR2 and FGFR3, which are fibroblast growth factor receptors. It is an FGFR2/3 inhibitor being studied in patients with cholangiocarcinoma and other advanced solid tumors that harbor FGFR2 or FGFR3 genetic alterations, such as gene fusions, rearrangements, amplifications, and short variants.
CGT4859 is being developed by Cogent Biosciences, Inc., a biopharmaceutical company traded on the stock exchange under the ticker COGT. The company is conducting a Phase 1 clinical trial of CGT4859 in patients with intrahepatic cholangiocarcinoma and other advanced solid tumors.
CGT4859 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 study is actively enrolling participants in the United States and Canada to evaluate the drug in patients with cholangiocarcinoma and other advanced solid tumors.
CGT4859 is being studied in a Phase 1 clinical trial with the identifier NCT06777316. The trial is titled 'A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors' and is currently active but not recruiting. The study has a planned enrollment of 110 participants.