Overview

Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

Status:
Completed
Trial end date:
2019-06-30
Target enrollment:
0
Participant gender:
All
Summary
This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Five Prime Therapeutics, Inc.
Treatments:
Bemarituzumab
Criteria
Inclusion Criteria:

- Life expectancy of at least 3 months

- ECOG performance status of 0 to 1

• In sexually-active patients, willingness to use 2 effective methods of contraception

- Adequate hematological and organ function, confirmed by lab values

- Tumor tissue must be available for prospective determination of FGFR2b overexpression

- Locally recurrent or metastatic disease that has progressed on or following
standard treatment, or is not a candidate for standard treatment

- Histologically or cytologically confirmed transitional cell carcinoma of the
genitourinary tract

- Measurable disease as defined by RECIST version 1.1

Exclusion Criteria:

- Untreated or symptomatic central nervous system (CNS) metastases

- Impaired cardiac function or clinically significant cardiac disease

- Treatment with any anticancer therapy or participation in another therapeutic
clinical study with investigational drugs Korea) prior to first dose of FPA144

- Ongoing acute adverse effects from prior anticancer or investigational therapy > NCI
CTCAE Grade 1

- Retinal disease or a history of retinal disease or detachment

- Corneal defects, corneal ulcerations, keratitis, keratoconus, history of corneal
transplant, or other known abnormalities of the cornea

- Major surgical procedures are not allowed ≤28 days prior to FPA144 administration

- Females who are pregnant or breastfeeding; women of childbearing potential must not be
considering getting pregnant during the study

- Presence of any serious or unstable concomitant systemic disorder incompatible with
the clinical study

- Known allergy or hypersensitivity to components of the FPA144 formulation including
polysorbate

- History of prior malignancy except:

- a) Curatively treated non-melanoma skin cancer or

- b) Solid tumor treated curatively more than 5 years previously without evidence of
recurrence or

- c) History of other malignancy that in the Investigator's opinion would not affect the
determination of study treatment effect

- Prior treatment with any selective inhibitor (e.g., AZD4547, BGJ398, JNJ-42756493,
BAY1179470) of the FGF-FGFR pathway