Actively Recruiting
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
Led by Tyra Biosciences, Inc · Updated on 2026-05-13
230
Participants Needed
5
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
CONDITIONS
Official Title
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years or older at time of informed consent and able to comply with study procedures
- Confirmed low risk low grade upper tract urothelial carcinoma per AUA guidelines
- Presence of at least 5mm of marker lesion remaining
- Availability of prior genomic report or archival/fresh tissue plus urine sample for genomic testing
- Identification of marker lesion(s) within 8 weeks before randomization
- If synchronous non-muscle invasive bladder cancer, it must be fully resected and low-grade Ta or T1
- No Bacillus Calmette-Guerin (BCG) treatment within 1 year before consent
- No intravesical chemotherapy within 8 weeks before first treatment day (Cycle 1 Day 1)
- No systemic chemotherapy within 3 months before first treatment day
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Pathology showing pure urothelial carcinoma
- Adequate bone marrow, liver, and kidney function according to lab criteria
You will not qualify if you...
- Evidence or features of high grade upper tract urothelial carcinoma
- History of carcinoma in situ (CIS)
- History of prostatic urethral involvement
- Current or past muscle invasive bladder cancer
- Current or past lymph node positive or metastatic bladder cancer
- Presence of squamous cell carcinoma, adenocarcinoma, undifferentiated carcinoma, or small cell carcinoma of the bladder
- Receiving systemic cancer therapy (cytotoxic or immunotherapy) currently
- Current or prior pelvic external beam radiotherapy for bladder cancer
- Prior use of an FGFR inhibitor
- Systemic immunotherapy within 6 months before randomization
- Treatment with investigational agents within 30 days or 5 half-lives before randomization
- Intravesical or intracavitary treatment within 8 weeks before first treatment day
- Current central serous retinopathy or retinal pigmented epithelial detachment at baseline
- Use of medications that inhibit or induce CYP3A enzyme as per prohibited list
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Duly Health and Care Chicago
Lisle, Illinois, United States, 60532
Actively Recruiting
2
First Urology
Jeffersonville, Indiana, United States, 47130
Actively Recruiting
3
Cleveland Clinic
Cleveland, Ohio, United States, 44111
Actively Recruiting
4
Urology Associates, P C
Nashville, Tennessee, United States, 37209-4035
Actively Recruiting
5
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Grace Indyk
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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