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)
A Phase 2A/B study of Dabogratinib (TYRA-300) in Low Grade Upper Tract Urothelial Carcinoma
• Participants ≥ 18 years of age at the time of informed consent and willing and able to comply with all required study procedures
• Confirmed LOW RISK LG UTUC (both favorable and unfavorable) per AUA
• At least 5mm of marker lesion left behind
• Participants must have previous genomic report or archival/fresh tissue in addition to urine sample for retrospective genomic testing
• 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 0-2
⁃ Pathology consists of pure urothelial carcinoma
⁃ Adequate bone marrow, liver, and renal function:
∙ i. Absolute neutrophil count (ANC) ≥1,500/mm3 ii. Platelet count ≥75,000/mm3 iii. Hemoglobin ≥10.0 g/dL
‣ i. Total bilirubin ≤ ULN ii. Alanine aminotransferase (ALT) ≤ ULN iii. Aspartate aminotransferase (AST) ≤ ULN
‣ Estimated glomerular filtration rate \>60 mL/min
‣ Serum Phosphate level ≤ ULN prior to starting treatment
‣ International normalized ratio (INR) ≤1.5 × ULN