Derazantinib and Atezolizumab in Patients With Urothelial Cancer

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basilea Pharmaceutica
• Treatments: Antibodies, Monoclonal; Atezolizumab

Criteria

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