Actively Recruiting
Phase 2A/B Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
Led by Tyra Biosciences, Inc · Updated on 2026-06-03
230
Participants Needed
7
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Dabogratinib (TYRA-300) in participants with Low Grade Upper Tract Urothelial Carcinoma (LG UTUC). This Phase 2A/B, multi-center, open-label study focuses on patients with confirmed low-risk LG UTUC, aiming to better understand the treatment's impact on this specific type of cancer. Participants receive Dabogratinib monotherapy in one of three dose groups: 60mg, 80mg, or a to-be-determined dose. The medication is taken daily as an oral tablet that participants self-administer. The study monitors participants over several months to assess response rates and other outcomes related to the treatment. Throughout the study, participants undergo regular assessments including genomic testing, imaging to identify marker lesions, and monitoring of blood and organ function. Researchers measure outcomes such as the proportion of participants achieving complete response within six months, safety and tolerability over two years, duration of response, renal preservation, and changes in tumor status. The study continues to observe participants for up to 36 months to evaluate long-term effects.
CONDITIONS
Brief 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 aged 18 years or older at the time of consent
- Confirmed low risk low grade upper tract urothelial carcinoma per AUA criteria
- At least 5mm of marker lesion remaining
- Previous genomic report or available tissue plus urine sample for genomic testing
- Marker lesions identified within 8 weeks before randomization
- If synchronous NMIBC, 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 prior to treatment start
- No systemic chemotherapy within 3 months prior to treatment start
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Pathology showing pure urothelial carcinoma
- Adequate bone marrow, liver, and kidney function as defined by lab values
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
- Evidence of squamous cell carcinoma, adenocarcinoma, undifferentiated carcinoma, or small cell bladder cancer
- Receiving systemic cancer therapy currently
- Past pelvic external beam radiotherapy for bladder cancer
- Previous treatment with FGFR inhibitors
- Systemic immunotherapy within 6 months before randomization
- Treatment with investigational agents within 30 days or 5 half-lives before randomization
- Intravesical or intracavitary agent treatment within 8 weeks before treatment start
- Current central serous retinopathy or retinal pigmented epithelial detachment at baseline
- Use of medications that affect CYP3A enzyme as prohibited
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants take Dabogratinib oral tablets daily as monotherapy to treat low grade upper tract urothelial carcinoma.
Regular visits during treatment period
Duration - Up to 2 years
Participants are monitored for safety, treatment response, and renal preservation after completing treatment.
Periodic visits for up to 2 years
Trial Site Locations
Total: 7 locations
1
Duly Health and Care Chicago
Lisle, Illinois, United States, 60532
Actively Recruiting
2
Urology of Indiana, LLC
Greenwood, Indiana, United States, 46143
Actively Recruiting
3
First Urology
Jeffersonville, Indiana, United States, 47130
Actively Recruiting
4
Greater Boston Urology - Plymouth Care Center
Plymouth, Massachusetts, United States, 02360
Actively Recruiting
5
Cleveland Clinic
Cleveland, Ohio, United States, 44111
Actively Recruiting
6
Urology Associates, P C
Nashville, Tennessee, United States, 37209-4035
Actively Recruiting
7
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Grace Indyk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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