Low Grade Upper Tract Urothelial Carcinoma
Conditions
Brief summary
Phase 2A: 1. Complete Response rate within 6 months. 2. Determination of the recommended dose for Phase 2B based on integrated safety, PK and efficacy data, Phase 2B: Complete Response rate within 6 months.
Detailed description
1. Complete Response rate within 6 months., 2. Duration of Response in participants with LG UTUC with FGFR3 altered tumours; Complete Response rate in 12months and 24 months. Response rate within 6 months., 3. Incidence and severity of Adverse Events, 4. PK parameters may include Cmax, Tmax, AUC0-last, AUCTau, AUC0-infinity, Vd/F, CL/F, and t1/2., 5. Proportion of participants who did not undergo nephrectomy or nephroureterectomy, 6. Proportion of participants with unresectable disease at baseline who convert to resectable disease or CR on dabogratinib, as assessed by the Investigator
Interventions
None listed
Sponsors
Tyra Biosciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2A: 1. Complete Response rate within 6 months. 2. Determination of the recommended dose for Phase 2B based on integrated safety, PK and efficacy data, Phase 2B: Complete Response rate within 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete Response rate within 6 months., 2. Duration of Response in participants with LG UTUC with FGFR3 altered tumours; Complete Response rate in 12months and 24 months. Response rate within 6 months., 3. Incidence and severity of Adverse Events, 4. PK parameters may include Cmax, Tmax, AUC0-last, AUCTau, AUC0-infinity, Vd/F, CL/F, and t1/2., 5. Proportion of participants who did not undergo nephrectomy or nephroureterectomy, 6. Proportion of participants with unresectable disease at baseline who convert to resectable disease or CR on dabogratinib, as assessed by the Investigator | — |
Outcome results
None listed