Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors; Gastric Cancer; Transitional Cell Carcinoma of the Bladder
MeSH terms: Carcinoma, Transitional Cell; Urinary Bladder Neoplasms
Intervention: FPA144
Intervention description: FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
Intervention MeSH terms: Bemarituzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FGFR2b, FGFR2, FGFR, bladder neoplasms, esophageal cancer

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.
    

Eligibility 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 </=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