Primary Outcomes:

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

Primary Outcome 1 - Time Frame: 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 - Time Frame: 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 - Time Frame: After enrollment of the first 10 patients in substudy 5

Condition:

• Urothelial Carcinoma

Eligibility

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 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No