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

RecruitingPhase 2Ages 18 Years - anyAllTyra Biosciences, Inc
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
* 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)
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What it tests

  • Dabogratinib (TYRA-300) 60mg
  • Dabogratinib (TYRA-300) 80mg
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Where

32 sites
Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM)
Loma Linda, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
Moffitt Cancer Center
Tampa, United States
The Winship Cancer Institute of Emory University
Atlanta, United States
Duly Health and Care Chicago
Lisle, United States
Urology of Indiana, LLC
Greenwood, United States
Indiana University (IU) Health Physicians - Urology
Indianapolis, United States
First Urology
Jeffersonville, United States

…and 24 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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