An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

Condition: Urothelial Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04045613

Sponsor: Basilea Pharmaceutica

Phase: Phase 1/Phase 2


  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histologically-confirmed transitional cell carcinoma of the urothelium of the upper or lower urinary tract
  • Recurrent or progressing stage IV disease, or surgically unresectable, recurrent or progressing disease
  • Documented central FGFR genetic aberration (FGFR1, FGFR2, or FGFR3 mutations / short variants and rearrangements / fusions)
  • Measurable disease per RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Receipt of chemotherapy, targeted therapies, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or at least 5 half-lives of the drug whichever is longer before the first dose of study drug.
  • Concurrent evidence of any clinically significant corneal or retinal disorder
  • Phosphatemia greater than institutional upper limit of normal (ULN) at screening
  • Uncontrolled tumor-related hypercalcemia

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