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

Amgen

Status and phase: Completed; Phase 1

Conditions: Gastric or Gastroesophageal Cancer

Treatments: Drug: FPA144

Study type: Interventional

Funder types: Industry

Identifiers

NCT05913115

FPA144-002

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

FPA144

Experimental group

Description:

Participants will receive escalating doses of FPA144. On completion of Cycle 1 (Cycles = 28 days in length) participants may participate in an optional Extended Treatment Period based on the Investigator's discretion, which begins on Day 1 of Cycle 2. FPA144 will be administered once every 2 weeks (Q2W) in 4-week cycles until disease progression, or until the patient meets any of the other withdrawal criteria.

Treatment:

Drug: FPA144