Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
← catalyst calendarNCT05544552 · readout ≤ 103 d
Sponsored by Tyra Biosciences, Inc (industry) · TYRA — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
310estimated
Sites
19
Countries
Australia, France, Spain +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-11-22 | actual | When the study began enrolling |
| Primary completion | Nov 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-09-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Locally Advanced Urothelial Carcinoma
- Metastatic Urothelial Carcinoma
- Solid Tumor
- Urothelial Carcinoma
- Solid Tumor, Adult
- Bladder Cancer
- Non-muscle-invasive Bladder Cancer
- FGFR3 Gene Mutation
- FGFR3 Gene Alteration
- Advanced Solid Tumor
- Advanced Urothelial Carcinoma
- Urinary Tract Cancer
- Urinary Tract Tumor
- Urinary Tract Carcinoma
Intervention
- Drug: TYRA-300
Primary outcomes
what the primary-completion date above is the date OFPhase 1 Part A: To determine the maximum tolerated doses (MTD).
measured Initiation of study treatment through 28 days.
Phase 1 Part B: To determine the recommended Phase 2 dose (R2PD).
measured Initiation of study treatment through 28 days (up to approximately 18 months).
Phase 2: Overall Response Rate (ORR), defined by RECIST v1.1.
measured Initiation of study treatment until disease progression, death, unacceptable toxicity, or withdrawal (up to 2 years).
Publications
- PMID 38573872 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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