Clinical Trial 24219

• Overview

  Study Title:

  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)

  Objective:

  Phase 2A: Primary Objectives: - To evaluate the efficacy of dabogratinib in participants with LG UTUC with FGFR3 altered tumors - To select the recommended dose for Phase 2B Secondary Objectives: - To evaluate the efficacy of dabogratinib in all participants with LG UTUC - To evaluate the therapeutic activity of dabogratinib - To evaluate the safety and tolerability of dabogratinib - To characterize the PK profile of dabogratinib - To determine rate of renal preservation after treatment with dabogratinib - To evaluate the change from unresectable to resectable disease after treatment with dabogratinib Phase 2B: Primary Objectives: - To evaluate the efficacy of dabogratinib in participants with LG UTUC with FGFR3 altered tumors. Secondary Objectives: - To evaluate the efficacy of dabogratinib in all participants with LG UTUC - To evaluate the therapeutic activity of dabogratinib - To evaluate the safety and tolerability of dabogratinib - To determine rate of renal preservation after treatment with dabogratinib - To evaluate the change from unresectable to resectable disease after treatment with dabogratinib - To characterize the PK profile of dabogratinib

• Treatments

  Therapies:

  FGFR3-selective inhibitor

  Medications:

  Dabogratinib ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • 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.

• Exclusion Criteria

  Key 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 randomization.
  • 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.
  • 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 potential inhibitors or inducers of CYP3A (prohibited list of medications).

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