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Completed

NCT Number: NCT05913115

A 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

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Key information

Conditions

Gastric or Gastroesophageal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Marianna University Hospital, Kawasaki-shi, Kanagawa, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FPA144

Drug

FPA144 will be administered intravenously Q2W.

Other names: Bemarituzumab

Primary outcomes

  1. Number of Participants who Experience Grade 3 or Grade 4 Dose-limiting Toxicities (DLTs)

    Time frame: Day 1 to Day 28 of Cycle 1

    DLTs are defined as specific adverse events (AEs) or clinically laboratory abnormalities that occur during the DLT observation period (Day 1 to Day 28 of Cycle 1; cycle = 28 days), that the Cohort Review Committee (CRC) assess as related to FPA144. Events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:

    • Grade 3: Severe or medically significant but non-immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE
    • Grade 4: Life-threatening consequences; urgent intervention indicated

  2. Area Under Serum Concentration-time Curve (AUC) of FPA144

    Time frame: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15

  3. Maximum Serum Concentration (Cmax) of FPA144

    Time frame: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15

  4. Trough Serum Concentration (Ctrough) of FPA144

    Time frame: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15

  5. Clearance (CL) of FPA144

    Time frame: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15

  6. Terminal Half-life (t1/2) of FPA144

    Time frame: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15

  7. Volume of Distribution of FPA144

    Time frame: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15

Secondary outcomes

  1. Number of Participants who Experience Treatment-emergent AEs (TEAEs)

    Time frame: Approximately 1 year

    TEAEs will be graded using the NCI CTCAE version 4.03. Any clinically significant laboratory abnormalities will also be reported as TEAEs.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.