Trial intelligence / Profile preview

TYRA-300 in FGFR3-altered urothelial carcinoma and solid tumors

NCT05544552Phase 2

Key facts

Status: Active, not recruiting
Start: Nov 2022
Primary completion: Nov 2026
Countries: 4
Sponsor: Tyra Biosciences
Modality: Small Molecules

Drugs: dabogratinib
Conditions: urothelial carcinoma (UC)solid tumor

Overview

Phase 2, open-label trial of dabogratinib in urothelial carcinoma (UC) and solid tumor (3 arms), sponsored by Tyra Biosciences. Primary endpoints: Maximum Tolerated Dose at 28 days, Recommended Phase 2 Dose at 28 days and 1 more. Started Nov 2022; status: active, not recruiting.

Design

3 arms

Study design: Non-randomizedOpen-labelSingle group

Phase 1 Part A - Dose Escalation
TYRA-300 dose escalation starting at 10 mg daily to determine MTD
Phase 1 Part B - Dose Expansion
TYRA-300 dose expansion to determine RP2D
Phase 2
TYRA-300 at RP2D in FGFR3-altered urothelial carcinoma and solid tumors

Who it enrols

Adults with advanced solid tumors harboring FGFR3 gene mutations or fusions who have exhausted standard therapies. Phase 2 includes urothelial carcinoma patients with or without prior FGFR inhibitor exposure, including those with resistance mutations.

Endpoints

Primary

Maximum Tolerated Dose28 days
Recommended Phase 2 Dose28 days
Overall Response Rateup to 2 years

Secondary

Adverse Eventsup to 2 years
Changes in Laboratory Parametersup to 2 years
Maximum Plasma ConcentrationCycle 3 Day 1
Time to Maximum Plasma ConcentrationCycle 3 Day 1
Area Under the Plasma Concentration-Time CurveCycle 3 Day 1
Half-lifeCycle 3 Day 1
Overall Response Rateup to 2 years
Duration of Responseup to 5 years

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