Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TYRA-300
Dabogratinib · 4 trials · 20 indications
Complete response (CR) rate
Complete response (CR) rate at 3 months
| Arm | Type | Description |
|---|---|---|
| Study Drug Dose Cohort A (DCA) 60mg | EXPERIMENTAL | Dabogratinib (TYRA-300) monotherapy in Participants |
| Study Drug Dose Cohort B (DCB) 80mg | EXPERIMENTAL | Dabogratinib (TYRA-300) monotherapy in Participants |
| 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 | TYRA-300 monotherapy in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer |
| TYRA-300 0.125 mg/kg | EXPERIMENTAL | TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months. |
| TYRA-300 0.25 mg/kg | EXPERIMENTAL | TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months. |
| TYRA-300 0.375 mg/kg | EXPERIMENTAL | TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months. |
| TYRA-300 0.50 mg/kg | EXPERIMENTAL | TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months. |
| TYRA-300 0.625 mg/kg | EXPERIMENTAL | TYRA-300 is provided as sprinkle capsules/mini-tablets. The total dose will be calculated based on the participant's weight. Weight adjustments will be made every 3 months. |
| 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 |
|---|---|---|
| Dabogratinib (TYRA-300) 60mg | DRUG | Self-administered 60mg dose Oral tablet(s) given daily |
| Dabogratinib (TYRA-300) 80mg | DRUG | Self-administered 80mg dose Oral tablet(s) given daily |
| 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 70 mg | DRUG | Self-administered 70 mg Oral tablet(s) given daily |
| TYRA-300 0.125 mg/kg | DRUG | Initial dose level of TYRA-300 per protocol, subsequent dose level escalations will occur based on criteria outlined in the protocol. |
| TYRA-300 0.25 mg/kg | DRUG | Subsequent dose level escalations will occur based on criteria outlined in the protocol. |
| TYRA-300 0.375 mg/kg | DRUG | Subsequent dose level escalations will occur based on criteria outlined in the protocol. |
| TYRA-300 0.50 mg/kg | DRUG | Subsequent dose level escalations will occur based on criteria outlined in the protocol. |
| TYRA-300 0.625 mg/kg | DRUG | Subsequent dose level escalations may occur based on criteria outlined in the protocol. |
| 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. |
* Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures * Confirmed LG UTUC (both favorable and unfavorable) per AUA * At least 5mm of marker lesion(s) left behind * Identification of marker lesion(s) within 8 weeks prior to ...
Dabogratinib is an investigational small molecule drug developed by Tyra Biosciences, Inc. (ticker TYRA) for FGFR3-driven conditions. It is being studied in achondroplasia and in several urothelial cancers, including locally advanced urothelial carcinoma, low grade upper tract urothelial carcinoma, and low-grade non-muscle invasive bladder cancer. It is also known as TYRA-300.
Dabogratinib targets FGFR3, a fibroblast growth factor receptor kinase. It belongs to the -tinib kinase inhibitor class, and its development focuses on cancers and skeletal conditions linked to FGFR3 gene alterations such as mutations, fusions, and amplifications.
Dabogratinib is being developed by Tyra Biosciences, Inc., which trades under the ticker TYRA. The company sponsors the clinical program for the drug across achondroplasia and FGFR3-altered urothelial cancers.
Dabogratinib is in Phase 2 clinical development. It is investigational and is being evaluated in recruiting Phase 2 studies as well as a Phase 1 study in advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations.
Dabogratinib trials include NCT07265947, a Phase 2A/B study in low grade upper tract urothelial carcinoma, and NCT06995677, a Phase 2 study in FGFR3-altered low grade, intermediate risk non-muscle invasive bladder cancer. The BEACH301 study in children with achondroplasia is NCT06842355, and NCT05544552 is a Phase 1 study in advanced urothelial carcinoma and other solid tumors.
Yes, dabogratinib is the same drug as TYRA-300. TYRA-300 is the development code used in trial titles and dosing labels such as TYRA-300 60mg and TYRA-300 0.125 mg/kg, while dabogratinib is the drug name.