A Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer

A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer

The main objectives of this study are:

• To determine the recommended dose (RD) of FPA144 in participants with gastric or gastroesophageal cancer (hereafter referred to as gastric cancer)
• To evaluate the safety of escalating doses of FPA144 in participants with gastric cancer
• To characterize the pharmacokinetic (PK) profile of single and multiple doses of intravenously administered FPA144 in participants with gastric cancer

Key Inclusion Criteria:

• Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma that is locally recurrent or metastatic and has progressed following standard treatment or is not appropriate for standard treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Adequate hematological, liver and kidney function. Measurable or non-measurable disease
• Archival tumor tissue for determination of FGFR2 status

Key Exclusion Criteria:

• Untreated or symptomatic central nervous system (CNS) metastases
• Clinically significant cardiac disease
• Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
• Active infection requiring systemic treatment
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
• Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
• Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
• Known positivity for human epidermal growth factor receptor 2 (HER2)
• Women who are pregnant or breastfeeding