for people ages 18 years and up (full criteria)
study started
estimated completion



This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A is the dose escalation phase for evaluating the safety and tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion phase in patients with metastatic urothelial carcinoma to further evaluate safety and tolerability, preliminary activity, PK, and PD in patients with FGFR genetic alterations.

Official Title

A Phase I Open-Label, Multicenter, Dose-Escalation Study of PRN1371, a FGFR 1-4 Kinase Inhibitor, in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Cohort in Patients With Metastatic Urothelial Carcinoma With FGFR 1, 2, 3, or 4 Genetic Alterations


The study is a dose escalation study. The protocol specifies rules for dose-limiting toxicity and a maximum tolerated dose (MTD). To gain further experience with the MTD, and/or at some lower optimal biologic dose level, an expansion cohort (Part B) will be enrolled in patients with metastatic urothelial carcinoma with fibroblast growth factor receptor (FGFR) 1, 2, 3 or 4 genetic alterations.


Solid Tumors Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter FGFR Carcinoma Carcinoma, Transitional Cell PRN1371


You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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).


  • UCSF Helen Diller Family Comprehensive Cancer Cener
    San Francisco California 94115 United States
  • The University of Texas MD Anderson Cancer Center
    Houston Texas 77030 United States


in progress, not accepting new patients
Start Date
Completion Date
Principia Biopharma Inc.
Phase 1
Study Type
Last Updated