English Español
Back to Clinical Trials

Brief Title: A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma

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


  • Org Study ID: PRN1371-001
  • Secondary ID: N/A
  • NTC ID: NCT02608125
  • Sponsor: Principia Biopharma Inc.


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.


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.

  • Overall Status
  • Start Date
    October 28, 2015
  • Phase
    Phase 1
  • Study Type


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 - Timeframe: 28 days on average


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


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

- 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

- Patients with glioblastoma multiforme

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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No


Name: Dolca Thomas, MD

Role: Study Director

Affiliation: Principia Biopharma

Overall Contact

Name: Dolca Thomas, MD

Phone: +16504167777

Email: clinicaltrials@principiabio.com


Facility Status Contact
Facility: Johns Hopkins Medicine
Baltimore, Maryland 21205
United States
Status: Recruiting Contact:
Noah Hahn, MD

Facility: Wake Forest University Health Sciences Medical Center
Winston-Salem, North Carolina 27157
United States
Status: Recruiting Contact:
Rhonda Biting, MD

Facility: Tennessee Oncology, Sarah Canon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact:
Todd Bauer

Facility: Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital
Barcelona, 08035
Status: Recruiting Contact:
Elena Garralda, MD

Facility: Hospital General Universitario de Elche
Elche, 03203
Status: Recruiting Contact:
Federico Vazquez Mazon

Facility: Hospital Universitario Ramon y Cajal
Madrid, 28034
Status: Recruiting Contact:
Pablo Gajate Borau

Facility: START Madrid-FJD Fundacion Jiminez Diaz
Madrid, 28040
Status: Recruiting Contact:
Victor Moreno, MD
+34 91 5504800
Facility: Hospital Universitario 12 de Octubre
Madrid, 28041
Status: Recruiting Contact:
Daniel Ernesto Castellano

Facility: START Madrid-CIOCC, Centro Integral Oncológico Clara Campal
Madrid, 28050
Status: Recruiting Contact:
Valentina Boni, MD
+34 91 7567825
Facility: Hospital Virgen del Rocio
Seville, 41013
Status: Recruiting Contact:
Begona Perez Valderrama