Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of treatment related Grade 3 and/or Grade 4 adverse events, defined as dose limiting toxicities, for the doses of PRN1371

Primary Outcome 1 - Time Frame: 28 days on average

Condition:

• Solid Tumors
• Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter

Eligibility

Criteria:
Inclusion Criteria:

- Age ≥ 18 years

- Histological or cytological documentation of an advanced solid tumor

- Subject must have metastatic or recurrent disease and have failed first-line systemic
treatment, and if indicated, failed approved second-line therapy, and for whom no
standard therapy options are anticipated to result in a durable remission

- Subject must have evaluable, progressive, and measurable disease per the Response
Evaluation Criteria in Solid Tumors (RECIST) guidelines, Version 1.1

- Adequate bone marrow, liver, and renal function

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

For Part B (expansion) in subjects metastatic urothelial carcinoma:

- The patient's tumor has been evaluated and prospectively identified as having FGFR 1,
2, 3, or 4 genetic alterations.

Exclusion Criteria:

- Patients who have received adequate prior treatment with a highly selective FGFR
inhibitor

- Patients with other major uncontrolled medical conditions, e.g., recent myocardial
infarction, stroke, diabetes, active hepatitis

- Patients who have received prior systemic anticancer therapy ≤ 3 weeks prior to study
start (6 weeks for nitrosourea, antibodies, or mitomycin-C)

- Patients diagnosed with another primary malignancy within 3 years prior to study
start, with the exception of adequately treated basal cell carcinoma, squamous cell
carcinoma, or other non-melanomatous skin cancer, or carcinoma in situ of the uterine
cervix

- Patients with glioblastoma multiforme

- Patient has a primary neoplasm of the brain or known uncontrolled metastases to the
central nervous system (CNS).
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No