BridgeMD
A multicenter, open-label, Phase 2 study of TYRA-300 in non-muscle invasive bladder cancer
EU CTIS ID: 2025-521277-14-00
What this study is testing
To evaluate the efficacy of dabogratinib.
- 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 aged 18 or older.
- 8. No prior BCG administration within 3 months of the date of consent.
- 9. No intravesical chemotherapy within 8 weeks prior to C1D1.
- 12. Adequate bone marrow, liver, and renal function.
- 10. Eastern Cooperative Oncology Group (ECOG) 0-1
- 11. Pathology consistent with pure urothelial carcinoma; if mixed histology, ensure that at least 80% of the sample is urothelial
You likely can't join if
- 1. Current or previous history of muscle invasive bladder cancer.
- 9. Prior treatment with an intravesical agent within 8 weeks of C1D1.
- 10. Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination as well as any active ocular abnormality at baseline that may increase the chance for ocular toxicity.
- 2. Current or previous history of lymph node positive and/or metastatic bladder cancer.
- 3. Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder.
- 4. Currently receiving systemic cancer therapy (cytotoxic or immunotherapy).
See the full eligibility criteria
- 1. Participants aged 18 or older.
- 8. No prior BCG administration within 3 months of the date of consent.
- 9. No intravesical chemotherapy within 8 weeks prior to C1D1.
- 12. Adequate bone marrow, liver, and renal function.
- 10. Eastern Cooperative Oncology Group (ECOG) 0-1
- 11. Pathology consistent with pure urothelial carcinoma; if mixed histology, ensure that at least 80% of the sample is urothelial
- 2. DCA. DCB and DCC (in enrolled) only: Participants with histologically confirmed low grade Non-Muscle Invasive Bladder Cancer (NMIBC) within 8 weeks prior to C1D1 with prior diagnostic biopsy/ Transurethral resection of bladder tumor (TURBT) to confirm stage and grade and with at least 3 mm and not more than 12 mm total residual visible tumor as a marker lesion(s) left behind: a. Ta low grade; b. T1 low grade.
- 3. Expansion Cohort only: Participants with histologically confirmed low-grade NMIBC within 8 weeks prior to C1D1 with prior diagnostic biopsy/TURBT to confirm stage and grade and with at least 3 mm residual visible tumor as a marker lesion(s) left behind:a. Ta low grade with or without focal high-grade; b. T1 low grade
- 4. Participants must have intermediate risk NMIBC, defined as having any of the following characteristics: a. Recurrence within 1 year, LG Ta; b. Solitary LG Ta >3cm; c. LG Ta, multifocal; d. LG T1.
- 5. Documented activating FGFR3 mutation or fusion.
- 6. Have undergone bladder mapping and identification of marker lesion(s) within 8 weeks prior to C1D1.
- 7. No evidence of urothelial carcinoma of the upper urinary tract (confirmed by imaging) or prostatic urethra within 6 months of C1D1.
- 1. Current or previous history of muscle invasive bladder cancer.
- 9. Prior treatment with an intravesical agent within 8 weeks of C1D1.
- 10. Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination as well as any active ocular abnormality at baseline that may increase the chance for ocular toxicity.
- 2. Current or previous history of lymph node positive and/or metastatic bladder cancer.
- 3. Evidence of pure squamous cell carcinoma, pure adenocarcinoma or pure undifferentiated carcinoma of the bladder.
- 4. Currently receiving systemic cancer therapy (cytotoxic or immunotherapy).
- 5. Current or prior history of pelvic external beam radiotherapy for bladder cancer.
- 6. Current or history of receiving a prior FGFR inhibitor.
- 7. Systemic immunotherapy for the treatment of cancer within 6 months prior to C1D1.
- 8. 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
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 United States; Australia. 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.