A Phase 1/2 interventional study of TYRA-300 in Locally Advanced Urothelial Carcinoma, Metastatic Urothelial Carcinoma and Solid Tumor, sponsored by Tyra Biosciences, Inc. Active, not recruiting at 19 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by Tyra Biosciences, Inc · Phase 1/2, Interventional, and Treatment
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.
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.
Phase 1 Part A and Part B
Phase 2
Histologically confirmed locally advanced/metastatic tumor in one of the following categories:
Exclusion Criteria (All Phases):
TYRA-300 taken once daily by mouth in 28-day cycles starting at 10 mg daily.
Drug: TYRA-300
TYRA-300 taken once or twice daily by mouth in 28-day cycles.
Drug: TYRA-300
TYRA-300 taken once or twice daily by mouth in 28-day cycles at doses determined during Phase 1.
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.
Phase 1 Part A: To determine the maximum tolerated doses (MTD).
Time frame: Initiation of study treatment through 28 days.
Phase 1 Part B: To determine the recommended Phase 2 dose (R2PD).
Time frame: Initiation of study treatment through 28 days (up to approximately 18 months).
Phase 2: Overall Response Rate (ORR), defined by RECIST v1.1.
Time frame: Initiation of study treatment until disease progression, death, unacceptable toxicity, or withdrawal (up to 2 years).
Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability.
Time frame: Initiation of study treatment through 28-days post treatment (up to 2 years).
Frequency in changes in laboratory parameters and physical signs of toxicity.
Time frame: Initiation of study treatment through 28-days post treatment (up to 2 years).
Pharmacokinetics: maximum plasma concentration (Cmax).
Time frame: Initiation of study treatment through Cycle 3 Day 1 (each cycle is 28 days).
Pharmacokinetics: time to reach maximum plasma concentration (Tmax).
Time frame: Initiation of study treatment through Cycle 3 Day 1(each cycle is 28 days).
Pharmacokinetics: area under the plasma concentration-time curve (AUC).
Time frame: Initiation of study treatment through Cycle 3 Day 1 (each cycle is 28 days).
Pharmacokinetics: half-life of TYRA-300 (t1/2).
Time frame: Initiation of study treatment through Cycle 3 Day 1 (each cycle is 28 days).
ORR is defined as the proportion of participants with complete response (CR) or partial response (PR) as determined by the investigator using RECIST V1.1.
Time frame: From enrollment, every 8 or 12 weeks (up to 2 years).
Duration of response will be defined as the time from the initial CR or PR to the time of relapse or death, whichever occurs first among participant with an objective response.
Time frame: From enrollment, every 8 or 12 weeks (up to 5 years).
Disease control rate is defined as the proportion of participants having a CR, PR or stable disease (SD) for >12 weeks.
Time frame: From enrollment up to 5 years.
Time to response is defined as time to first CR or PR that is subsequently confirmed according to RECIST v1.1.
Time frame: Up to 5 years.
Progression-free survival is defined as the time from the date of first study drug administration to the earliest date of documented disease progression or death.
Time frame: From the date of the first dose of study drug until disease progression or death as assessed up to the last efficacy assessment for disease progression (up to 5 years)].
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Tyra Biosciences, Inc