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Also known as TYRA-300 60mg
TYRA-300 · 2 trials · 18 indications
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| Arm | Type | Description |
|---|---|---|
| Dose Cohort A (DCA) | EXPERIMENTAL | TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer |
| Dose Cohort B (DCB) | EXPERIMENTAL | TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer |
| Possible Dose Cohort C (DCC) | EXPERIMENTAL | To Be Determined- TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer |
| Phase 1 Part A - dose escalation | EXPERIMENTAL | TYRA-300 taken once daily by mouth in 28-day cycles starting at 10 mg daily. |
| Phase 1 Part B - dose expansion | EXPERIMENTAL | TYRA-300 taken once or twice daily by mouth in 28-day cycles. |
| Phase 2 | EXPERIMENTAL | TYRA-300 taken once or twice daily by mouth in 28-day cycles at doses determined during Phase 1. |
| Name | Type | Description |
|---|---|---|
| TYRA-300 60mg | DRUG | Self-administered 60mg dose Oral tablet(s) given daily |
| TYRA-300 50mg | DRUG | Self-administered 50mg dose Oral tablet(s) given daily |
| TYRA-300 Dose TBD | DRUG | To Be Determined Dose: Self-administered Oral tablet(s) given daily |
| TYRA-300 | DRUG | TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3. |
Inclusion Criteria: * Participants age 18 and over of informed consent and willing and able to comply with all requires study procedures * Able to understand and given written informed consent * Participants with histologically confirmed low-grade NMIBC within 6 weeks prior to randomization with pr...
TYRA-300 is an investigational small molecule being studied for achondroplasia, locally advanced urothelial carcinoma, and low-grade non-muscle invasive bladder cancer (NMIBC). It is in clinical development for these conditions and has not been approved by the FDA.
TYRA-300 targets FGFR3, a receptor tyrosine kinase. It is designed to act on FGFR3 alterations, which are relevant in certain cancers and achondroplasia. The drug is being evaluated in patients with FGFR3 gene mutations, amplifications, and fusions.
TYRA-300 is being developed by Tyra Biosciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TYRA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple patient populations.
TYRA-300 is in Phase 1 and Phase 2 clinical trials. A Phase 1 study is active but not recruiting, while two Phase 2 studies are currently recruiting participants. The drug remains investigational and is not yet approved for any indication.
TYRA-300 is being studied in three trials: NCT05544552, a Phase 1 study in advanced urothelial carcinoma and other solid tumors with FGFR3 alterations; NCT06842355, a Phase 2 study in children with achondroplasia; and NCT06995677, a Phase 2 study in low-grade NMIBC with FGFR3 alterations.
Yes, TYRA-300 60mg, TYRA-300 0.125 mg/kg, and TYRA-300/kg are alternative names for the same drug, TYRA-300. These names reflect different dosing formulations or concentrations used in clinical trial protocols.