BridgeMD
A study to investigate dabogratinib (TYRA-300) in participants with Low Grade Upper Tract Urothelial Carcinoma
EU CTIS ID: 2025-523539-20-00
What this study is testing
Phase 2A: 1. To evaluate the efficacy of dabogratinib in participants with LG UTUC with FGFR3 altered tumors. 2. To select the recommended dose for Phase 2B. Phase 2B: To evaluate the efficacy of dabogratinib in participants with LG UTUC with FGFR3 altered tumors.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
- 10. ECOG 0-2
- 11. Pathology consists of pure urothelial carcinoma
- 12. Adequate bone marrow, liver, and renal function.
- 2. Confirmed LG UTUC.
- 3. At least 5mm of marker lesion left behind
You likely can't join if
- 1. Evidence or any features of high grade (HG) UTUC
- 10. Systemic immunotherapy within 6 months prior to randomization
- 11. Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will be default to 30 days.
- 12. Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1
- 13. Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination
- 14. Requiring use of medications that are potential inhibitors or inducers of CYP3A (prohibited list of medications)
See the full eligibility criteria
- 1. Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
- 10. ECOG 0-2
- 11. Pathology consists of pure urothelial carcinoma
- 12. Adequate bone marrow, liver, and renal function.
- 2. Confirmed LG UTUC.
- 3. At least 5mm of marker lesion left behind
- 4. Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing
- 5. Identification of marker lesion(s) within 8 weeks prior to randomization
- 6. If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1.
- 7. No prior BCG administration within 1 year of date of consent
- 8. No intravesical chemotherapy within 8 weeks prior to C1D1 (including UGN-101).
- 9. No systemic chemotherapy within 3 months prior to C1D1
- 1. Evidence or any features of high grade (HG) UTUC
- 10. Systemic immunotherapy within 6 months prior to randomization
- 11. Treatment with an investigational agent within 30 days or 5 half-lives from randomization, whichever is shorter; compounds with an unknown half-life will be default to 30 days.
- 12. Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1
- 13. Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination
- 14. Requiring use of medications that are potential inhibitors or inducers of CYP3A (prohibited list of medications)
- 2. History of carcinoma in situ (CIS)
- 3. History of prostatic urethral involvement
- 4. Current or previous history of muscle invasive bladder cancer
- 5. Current or previous history of lymph node positive and/or metastatic bladder cancer
- 6. Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
- 7. Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
- 8. Current or prior history of pelvic external beam radiotherapy for bladder cancer
- 9. Current or history of receiving a prior FGFR inhibitor
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.