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Keep this study
Lead
Five Prime Therapeutics, Inc.
Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients.
Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 \</=14 days (\</=28 days for patients in 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
Clareo Health | Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
