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Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-11-22
Primary completion: 2026-11-01
Study completion finish: 2027-06-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05544552
Intervention or treatment
DRUG: TYRA-300
Conditions
- • Solid Tumor
- • Urothelial Carcinoma
- • Solid Tumor, Adult
- • Bladder Cancer
- • Advanced Solid Tumor
- • Locally Advanced Urothelial Carcinoma
- • Metastatic Urothelial Carcinoma
- • Non-muscle-invasive Bladder Cancer
- • FGFR3 Gene Mutation
- • FGFR3 Gene Alteration
- • Advanced Urothelial Carcinoma
- • Urinary Tract Cancer
- • Urinary Tract Tumor
- • Urinary Tract Carcinoma
Find a site
Closest Location:
Macquarie University
Research sites nearby
Select from list below to view details:
Macquarie University
Macquarie Park, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Phase 1 Part A - dose escalation
| DRUG: TYRA-300
|
EXPERIMENTAL: Phase 1 Part B - dose expansion
| DRUG: TYRA-300
|
EXPERIMENTAL: Phase 2
| DRUG: TYRA-300
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Phase 1 Part A: To determine the maximum tolerated doses (MTD). | Not Specified | Initiation of study treatment through 28 days. |
Phase 1 Part B: To determine the recommended Phase 2 dose (R2PD). | Not Specified | Initiation of study treatment through 28 days (up to approximately 18 months). |
Phase 2: Overall Response Rate (ORR), defined by RECIST v1.1. | Not Specified | Initiation of study treatment until disease progression, death, unacceptable toxicity, or withdrawal (up to 2 years). |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Number of participants with adverse events (AEs) and serious adverse events (SAEs) as a measure of safety and tolerability. | Not Specified | Initiation of study treatment through 28-days post treatment (up to 2 years). |
Frequency in changes in laboratory parameters and physical signs of toxicity. | Not Specified | Initiation of study treatment through 28-days post treatment (up to 2 years). |
Pharmacokinetics: maximum plasma concentration (Cmax). | Not Specified | Initiation of study treatment through Cycle 3 Day 1 (each cycle is 28 days). |
Pharmacokinetics: time to reach maximum plasma concentration (Tmax). | Not Specified | Initiation of study treatment through Cycle 3 Day 1(each cycle is 28 days). |
Pharmacokinetics: area under the plasma concentration-time curve (AUC). | Not Specified | Initiation of study treatment through Cycle 3 Day 1 (each cycle is 28 days). |
Pharmacokinetics: half-life of TYRA-300 (t1/2). | Not Specified | 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. | Not Specified | 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. | Not Specified | 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. | Not Specified | 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. | Not Specified | 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. | Not Specified | 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)]. |
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