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Also known as TYRA-300, Dabogratinib (TYRA-300) TBD, Dabogratinib TBD, TYRA-300 Dose TBD
Dabogratinib · 4 trials · 20 indications
Complete response (CR) rate
Complete response (CR) rate
| 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 |
| Possible Study Drug Dose Cohort C (DCC) TBD mg | 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 | To Be Determined- 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 |
| Dabogratinib (TYRA-300) TBD | DRUG | To be determined: Self-administered 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 TBD | DRUG | To Be Determined Dose: Self-administered 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. |
1. Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures 2. Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA 3. At least 5mm of marker lesion left behind 4. Participants must have previous genomic report or...
Dabogratinib is an investigational small molecule 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 not yet approved for any indication and remains in clinical development.
Dabogratinib targets FGFR3, a fibroblast growth factor receptor kinase. It belongs to the -tinib class of kinase inhibitors. FGFR3 alterations, including mutations, fusions, and amplifications, are relevant to the bladder cancer and urothelial carcinoma populations being studied, while FGFR3 signaling also plays a role in achondroplasia, a skeletal growth condition.
Dabogratinib is being developed by Tyra Biosciences, Inc., which trades on the Nasdaq under the ticker TYRA. The company is running the clinical program for the drug across skeletal dysplasia and oncology indications.
Dabogratinib is in Phase 2 development. It is investigational and has not been approved by the FDA or any other regulatory agency. The Phase 2 studies are currently recruiting, and an earlier Phase 1 study in advanced urothelial carcinoma and other FGFR3-altered solid tumors is active but no longer recruiting.
Dabogratinib is being tested in four registered studies. NCT07265947 is a Phase 2A/B trial in low grade upper tract urothelial carcinoma. NCT06995677 is a Phase 2 trial in FGFR3-altered low grade, intermediate risk non-muscle invasive bladder cancer. NCT06842355, called BEACH301, is a Phase 2 study in children with achondroplasia. NCT05544552 is a Phase 1 study in advanced urothelial carcinoma and other FGFR3-altered solid tumors.
Yes. Dabogratinib is the same investigational drug as TYRA-300. Tyra Biosciences uses TYRA-300 as its development code name, and trial listings also refer to dose-specific labels such as TYRA-300 60mg and TYRA-300 0.125 mg/kg. Searches for either name refer to the same FGFR3-targeted small molecule.