Dabogratinib treatment for low-grade upper tract urothelial carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2A/B, multi-center, open-label trial giving oral dabogratinib at planned dose levels to adults with low-grade upper tract urothelial carcinoma who have a measurable marker lesion. Participants must have tissue or urine available for genomic testing and a marker lesion of at least 5 mm left in place before treatment. The study follows patients for tumor response and safety outcomes across dose cohorts (including 60 mg and 80 mg arms and an additional dose to be determined). Key eligibility includes confirmed low-risk low-grade UTUC, ECOG 0-2, and adequate organ function.

Why it matters

Who can join: the full rules

* 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)

Where it's running

• Loma Linda University (LLU) - Loma Linda University Medical Center (LLUM)
  Loma Linda, California, United States Recruiting
• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• The Winship Cancer Institute of Emory University
  Atlanta, Georgia, United States Recruiting
• The University of Chicago
  Chicago, Illinois, United States Recruiting
• Duly Health and Care Chicago
  Lisle, Illinois, United States Recruiting

Study contacts

• Study coordinator: Lara Balick
• Email: TyraClinicalTrials@tyra.bio
• Phone: 929-792-5633

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Non-invasive urine test to screen for urothelial cancer in adults with blood in urine

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• Flexible ureteroscopy to monitor upper tract urothelial carcinoma

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• Disitamab Vedotin Plus Radiotherapy for HER2-Expressing Upper Tract Urothelial Carcinoma After Surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.