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Tests treatment safety and results for Low Grade Upper Tract Urothelial Carcinoma
Official title Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
ClinicalTrials.gov ID: NCT07265947
What this study is testing
What is Dabogratinib (TYRA-300) 60mg?
Dabogratinib (TYRA-300) 60mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for low grade upper tract urothelial carcinoma.
Also referred to as TYRA-300.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
- Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA
- At least 5mm of marker lesion left behind
- Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing
- Identification of marker lesion(s) within 8 weeks prior to randomization (refer to Inclusion Criterion #2)
You likely can't join if
- Evidence or any features of high grade (HG) UTUC
- History of carcinoma in situ (CIS)
- History of prostatic urethral involvement
- Current or previous history of muscle invasive bladder cancer
- Current or previous history of lymph node positive and/or metastatic bladder cancer
- Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
See the full eligibility criteria
- Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
- Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA
- At least 5mm of marker lesion left behind
- Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing
- Identification of marker lesion(s) within 8 weeks prior to randomization (refer to Inclusion Criterion #2)
- If synchronous NMIBC, NMIBC must be fully resected and low-grade Ta or T1
- No prior BCG administration within 1 year of date of consent.
- No intravesical chemotherapy within 8 weeks prior to C1D1 (including UGN-101).
- No systemic chemotherapy within 3 months prior to C1D1
- ECOG 0-2
- Pathology consists of pure urothelial carcinoma
- Adequate bone marrow, liver, and renal function:
- i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL
- i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN
- Estimated glomerular filtration rate \>60 mL/min
- Serum Phosphate level ≤ ULN prior to starting treatment
- International normalized ratio (INR) ≤1.5 × ULN
- Evidence or any features of high grade (HG) UTUC
- History of carcinoma in situ (CIS)
- History of prostatic urethral involvement
- Current or previous history of muscle invasive bladder cancer
- Current or previous history of lymph node positive and/or metastatic bladder cancer
- Evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma or small cell of the bladder
- Currently receiving systemic cancer therapy (cytotoxic or immunotherapy)
- Current or prior history of pelvic external beam radiotherapy for bladder cancer
- Current or history of receiving a prior FGFR inhibitor
- Systemic immunotherapy within 6 months prior to randomization
- 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.
- Prior treatment with an intravesical or intracavitary agent within 8 weeks of C1D1.
- Current evidence of central serous retinopathy or retinal pigmented epithelial detachment of any grade at time of baseline examination.
- Requiring use of medications that are potential inhibitors or inducers of CYP3A (prohibited list of medications)
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Lisle, Illinois, United States
- Greenwood, Indiana, United States
- Jeffersonville, Indiana, United States
- Plymouth, Massachusetts, United States
- St Louis, Missouri, United States
- Sewell, New Jersey, United States
- Albany, New York, United States
- Syracuse, New York, United States
- Cleveland, Ohio, United States
- Gahanna, Ohio, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Cadiz, Spain
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Lisle, Illinois, United States; Greenwood, Indiana, United States; Jeffersonville, Indiana, United States; Plymouth, Massachusetts, United States; St Louis, Missouri, United States and 9 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.