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Derazantinib and Atezolizumab in Patients With Urothelial Cancer

Trial Status: Active

The purpose of this study is to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

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 alteration (FGFR1, FGFR2, or FGFR3 mutations 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


New Haven
Yale University
Status: ACTIVE


UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479
M D Anderson Cancer Center
Status: ACTIVE


University of Virginia Cancer Center
Status: ACTIVE

The study comprises five open-label substudies in patients with advanced urothelial cancer

harboring FGFR GA who will be treated by derazantinib monotherapy or derazantinib in

combination with atezolizumab. The study enrolls patients with cisplatin-ineligible status,

or patients whose disease progressed after either first-line treatment or prior treatment

with FGFR inhibitors.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Basilea Pharmaceutica

  • Primary ID DZB-CS-201
  • Secondary IDs NCI-2019-08162, 2019-000359-15
  • ID NCT04045613