A Study of IMAB362 in Japanese Subjects With Locally Advanced or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Sponsor
Astellas Pharma Inc
Study ID
NCT03528629
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zolbetuximab — DRUG
    Zolbetuximab will be administered as a 2-hour intravenous infusion.

Study Details

The purpose of this study is to assess the safety, tolerability and antitumor activity of IMAB362 in Japanese subjects with locally advanced or metastatic Gastric or GEJ adenocarcinoma whose tumors have Claudin (CLDN) 18.2 Expression. This study will also assess pharmacokinetics and immunogenicity of IMAB362.

Key Dates

Start date
Jun 8, 2018
Status verified
Nov 2024
Primary completion
Jun 9, 2020
Completion
Jun 9, 2020

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Part Arm A (IMAB362 dose-1/2)
    Participants will receive a loading dose-1 of IMAB362 on Cycle 1 Day 1 followed by a lower dose-2 in subsequent every 3 weeks.
  • Experimental: Safety Part Arm B (IMAB362 dose-3)
    Participants will receive a loading dose-3 of IMAB362 on Day 1 of each cycle (every 3 weeks).
  • Experimental: Expansion Part (IMAB362 dose-1/2)
    Participants will receive a loading dose-1 of IMAB362 on Cycle 1 Day 1 followed by a lower dose-2 in subsequent every 3 weeks.

Primary Outcome Measure

Dose Limiting Toxicities (DLT) in Safety Part [ Time Frame: Up to Day 22 ]

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