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)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma
