Trials / Active Not Recruiting
Active Not RecruitingNCT05544552
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
A Multicenter, Open-label Phase 1/2 Study of TYRA300 in Advanced Urothelial Carcinoma and Other Solid Tumors With Activating FGFR3 Gene Alterations (SURF301)
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- Sponsor
- Tyra Biosciences, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.
Detailed description
This is a single arm, multi-part, phase 1/2 global trial studying TYRA-300, a novel, potent fibroblast growth factor receptor (FGFR) 3-selective tyrosine kinase inhibitor, in advanced/metastatic urothelial carcinoma of the bladder and urinary tract, that contain activating gene alterations of FGFR3. Phase 1 is a dose-escalation study to evaluate the safety, tolerability, and PK of TYRA-300 to determine the optimal and maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Phase 2 will evaluate the preliminary antitumor activity of TYRA-300 in cancers with FGFR3 activating gene alterations, including locally advanced/metastatic urothelial carcinoma of the bladder and urinary tract and other advanced solid tumors.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TYRA-300 | TYRA-300 is an oral, novel potent FGFR 3-selective tyrosine kinase inhibitor that targets tumors that contain activating gene alterations of FGFR3. |
Timeline
- Start date
- 2022-11-22
- Primary completion
- 2026-11-01
- Completion
- 2027-06-01
- First posted
- 2022-09-16
- Last updated
- 2026-01-12
Locations
19 sites across 4 countries: United States, Australia, France, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05544552. Inclusion in this directory is not an endorsement.