A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521277-14-00

Acronym

TYR300-202

Enrollment

Registered

2025-10-08

Start date

2025-12-09

Completion date

Unknown

Last updated

2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-muscle invasive bladder cancer (NMIBC)

Brief summary

Complete response (CR) rate at 3 months

Detailed description

-Duration of response (responders only)., -Time to recurrence (responders only), -Recurrence-free survival rate at 12 months and 24 months (responders only), -Progression-free survival (all participants), -Cmax, Tmax, AUC0-last, AUCTau, AUC0-infinity, Vd/F, CL/F, and t1/2., -Incidence and severity of adverse events, incidence of impact on study drug dosing, changes in clinical laboratory parameters, vital sign changes.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
-Duration of response (responders only)., -Time to recurrence (responders only), -Recurrence-free survival rate at 12 months and 24 months (responders only), -Progression-free survival (all participants), -Cmax, Tmax, AUC0-last, AUCTau, AUC0-infinity, Vd/F, CL/F, and t1/2., -Incidence and severity of adverse events, incidence of impact on study drug dosing, changes in clinical laboratory parameters, vital sign changes.	—

Measure

Time frame

—

Primary

Measure	Time frame
Complete response (CR) rate at 3 months	—

Countries

France, Italy, Spain

Outcome results