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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
Phase
Phase 2
Started
2025-12-22
Last updated
2026-10-16

Condition(s) studied

Low Grade Upper Tract Urothelial Carcinoma

Investigational drug(s) / intervention(s)

Dabogratinib (TYRA-300) 60mg →Dabogratinib (TYRA-300) 80mg →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
* 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)

FacilityCityRegionStatus
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
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