Brief Title: Derazantinib and Atezolizumab in Patients With Urothelial Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Overall Response Rate (ORR) based on RECIST 1.1

Primary Outcome 1 - Timeframe: Approximately up to 2 years

Primary Outcome 2 - Measure: Safety and tolerability of derazantinib 200 mg twice a day with atezolizumab 1200 mg every three weeks

Primary Outcome 2 - Timeframe: After enrollment of the first 10 patients in substudy 3

Primary Outcome 3 - Measure: Safety and tolerability of derazantinib 200 mg twice a day as monotherapy

Primary Outcome 3 - Timeframe: After enrollment of the first 10 patients in substudy 5

CONDITION

• Urothelial Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Manuel Häckl, MD

Role: Study Director

Affiliation: Basilea Pharmaceutica International Ltd

Overall Contact

Name: Manuel Häckl, MD

Phone: +41 76 302 53 10, +41 61 567 15 46

Email: manuel.haeckl@basilea.com, marc.engelhardt@basilea.com

LOCATION