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NCT07265947PHASE2Recruiting

Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma

Tyra Biosciences, Inc

Start Date

12/22/2025

Completion Date

11/1/2030

Summary

A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma

Detailed Description

A Phase 2A/B, Multi-center, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303)

Eligibility Criteria

Age Range: 18 years to No maximum

1. Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures 2. Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA 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 (refer to Inclusion Criterion #2) 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 10. ECOG 0-2 11. Pathology consists of pure urothelial carcinoma 12. Adequate bone marrow, liver, and renal function: 1. i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL 2. i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN 3. Estimated glomerular filtration rate \>60 mL/min 4. Serum Phosphate level ≤ ULN prior to starting treatment 5. International normalized ratio (INR) ≤1.5 × ULN Exclusion Criteria: 1. Evidence or any features of high grade (HG) UTUC 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 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)

Interventions

DRUG

Dabogratinib (TYRA-300) 60mg

DRUG

Dabogratinib (TYRA-300) 80mg

DRUG

Dabogratinib (TYRA-300) TBD

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Conditions

Low Grade Upper Tract Urothelial Carcinoma

Locations

Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM)

Loma Linda, California 92354-3450

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Moffitt Cancer Center

Tampa, Florida 33612-9416

United States

The Winship Cancer Institute of Emory University

Atlanta, Georgia 30322-1013

United States

Duly Health and Care Chicago

Lisle, Illinois 60532

United States

Urology of Indiana, LLC

Greenwood, Indiana 46143

United States

Indiana University (IU) Health Physicians - Urology

Indianapolis, Indiana 46202

United States

First Urology

Jeffersonville, Indiana 47130

United States

Greater Boston Urology - Plymouth Care Center

Plymouth, Massachusetts 02360

United States

University of Michigan Health System (UMHS)

Ann Arbor, Michigan 48109-5000

United States

Michigan Healthcare Professionals - William Beaumont University Hospital

Royal Oak, Michigan 48073-0996

United States

Urology of St. Louis

St Louis, Missouri 63141

United States

Summit Health - Washington Township

Sewell, New Jersey 08080-2359

United States

Albany Medical College

Albany, New York 12208-3412

United States

Associated Medical Professionals of NY, PLLC

Syracuse, New York 13210

United States

Cleveland Clinic

Cleveland, Ohio 44111

United States

Central Ohio Urology Group

Gahanna, Ohio 43230

United States

Penn Medicine Radnor

Radnor, Pennsylvania 19087

United States

Medical University of South Carolina (MUSC)

Mt. Pleasant, South Carolina 29464-3771

United States

Urology Associates, P C

Nashville, Tennessee 37209-4035

United States

Urology Austin - Apex Cancer Care - Austin

Austin, Texas 78705-2009

United States

The University of Texas Southwestern Medical Center

Dallas, Texas 75235

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Hopital Pitie-Salpetriere

Paris, 75013

France

Hôpital Européen Georges Pompidou (HEGP)

Paris, 75015

France

Edith Wolfson Medical Center

Holon, Tel Aviv 5822012

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv 6423906

Israel

Hadassah University Hospital - Ein Kerem

Jerusalem,

Israel

Meir Medical Center

Kfar Saba, 4428164

Israel

Hospital Universitari i Politècnic La Fe

Valencia, Valencia 46026

Spain

Hospital Universitario Puerta del Mar

Cadiz, 11009

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain