Clinical Trials in France / NCT07265947
Recruiting
Phase 2
Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
NCT07265947 · tracked via the Priya Life Science France tracker
Condition(s) studied
Low Grade Upper Tract Urothelial Carcinoma
Investigational drug(s) / intervention(s)
Dabogratinib (TYRA-300) 60mg: Self-administered 60mg dose Oral tablet(s) given daily
Dabogratinib (TYRA-300) 80mg: Self-administered 80mg dose Oral tablet(s) given daily
Study summary
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
Eligibility
* Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
* Confirmed LG UTUC (both favorable and unfavorable) per AUA
* At least 5mm of marker lesion(s) left behind
* 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 PS 0-2
* Pathology consists of pure urothelial carcinoma
* Adequate bone marrow function:
i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL
* Adequate liver function:
i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN
* Adequate renal function:
i. Estimated glomerular filtration rate \>30 mL/min ii. Serum Phosphate level ≤ ULN prior to starting treatment iii. International normalized ratio (INR) ≤1.5 × ULN
Exclusion Criteria:
* 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 C1D1
* Treatment with an investigational agent within 30 days or 5 half-lives from C1D1, 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 strong and moderate inhibitors or inducers of CYP3A or inhibitors of P-gp and BCRP transporters (prohibited list of medications)
Primary outcome measure(s)
- To assess the efficacy of Dabogratinib in LG UTUC FGFR3+ participants (proportion of participants with a CR within 6 months out of all LG UTUC FGFR3+ participants) — within 6 months
Complete response (CR) rate
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM) | Loma Linda | California | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | Recruiting |
| The Winship Cancer Institute of Emory University | Atlanta | Georgia | Recruiting |
| Duly Health and Care Chicago | Lisle | Illinois | Recruiting |
| Urology of Indiana, LLC | Greenwood | Indiana | Recruiting |
| Indiana University (IU) Health Physicians - Urology | Indianapolis | Indiana | Recruiting |
| First Urology | Jeffersonville | Indiana | Recruiting |
| Greater Boston Urology - Plymouth Care Center | Plymouth | Massachusetts | Recruiting |
| University of Michigan Health System (UMHS) | Ann Arbor | Michigan | Recruiting |
| Michigan Healthcare Professionals - William Beaumont University Hospital | Royal Oak | Michigan | Recruiting |
| Urology of St. Louis | St Louis | Missouri | Recruiting |
| Summit Health - Washington Township | Sewell | New Jersey | Recruiting |
| Albany Medical College | Albany | New York | Recruiting |
| Associated Medical Professionals of NY, PLLC | Syracuse | New York | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| Central Ohio Urology Group | Gahanna | Ohio | Recruiting |
| Penn Medicine Radnor | Radnor | Pennsylvania | Recruiting |
| Medical University of South Carolina (MUSC) | Mt. Pleasant | South Carolina | Recruiting |
| Urology Associates, P C | Nashville | Tennessee | Recruiting |
| Urology Austin - Apex Cancer Care - Austin | Austin | Texas | Recruiting |
| The University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Hopital Pitie-Salpetriere | Paris | France | Recruiting |
| Hôpital Européen Georges Pompidou (HEGP) | Paris | France | Recruiting |
| Edith Wolfson Medical Center | Holon | Tel Aviv | Recruiting |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Tel Aviv | Recruiting |
| Hadassah University Hospital - Ein Kerem | Jerusalem | Israel | Recruiting |
| Meir Medical Center | Kfar Saba | Israel | Recruiting |
| Hospital Universitari i Politècnic La Fe | Valencia | Valencia | Recruiting |
| Hospital Universitario Puerta del Mar | Cadiz | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
More Tyra Biosciences, Inc trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07265947 on ClinicalTrials.gov ↗ ← All trials in France