Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TYRA-200 · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Phase 1 Part A and Part B | EXPERIMENTAL | TYRA-200 taken once daily by mouth in 28-day cycles |
| Name | Type | Description |
|---|---|---|
| Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles | DRUG | TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2. |
| Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles | DRUG | TYRA-200 is an oral, novel potent FGFR 1/2/3 tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR2. |
Inclusion Criteria: Phase 1 Part A * Men and women 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. * Any histologically confirmed advanced solid tumor with FGFR/FGF pathway alterations including FGFR gene mutations, fusions, and amplifications, as we...
TYRA-200 is an investigational small molecule being studied for locally advanced cholangiocarcinoma, including intrahepatic and metastatic forms, in patients whose tumors have activating FGFR2 gene alterations. It is also being evaluated in solid tumors. It is not approved and remains in clinical development.
TYRA-200 targets FGFR1, FGFR2, and FGFR3, part of the fibroblast growth factor receptor (FGFR) family. It is designed as a small molecule inhibitor of these receptors, and the Phase 1 trial enrolls patients selected for activating FGFR2 gene alterations in their tumors.
TYRA-200 is being developed by Tyra Biosciences, Inc., which trades on the Nasdaq under the ticker TYRA. The company is the sponsor of the Phase 1 study evaluating the drug in advanced cholangiocarcinoma with activating FGFR2 gene alterations.
TYRA-200 is in Phase 1 clinical development. The program includes a dose escalation part and a dose expansion part, with TYRA-200 taken once daily by mouth in 28-day cycles. It is investigational and has not been approved by the FDA.
TYRA-200 is being evaluated in the Phase 1 trial NCT06160752, titled Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations. The study is active but not recruiting, plans to enroll 40 participants, and is conducted in the United States.