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

Sponsor
Astellas Pharma China, Inc.
Study ID
NCT04086758
Phase
PHASE1
Status
Completed

Conditions

  • Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Eligibility Criteria

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

Interventions

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

Study Details

A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects with Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma

Key Dates

Start date
Oct 18, 2019
Status verified
Nov 2024
Primary completion
Jan 22, 2021
Completion
Jan 22, 2021

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zolbetuximab
    Participants will receive a loading dose-1 of zolbetuximab on Day 1 of Cycle 1, consists of 21 days, followed by subsequent lower dose-2 every 3 weeks until they meet the discontinuation criteria.

Primary Outcome Measure

Pharmacokinetics (PK) of zolbetuximab: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf) [ Time Frame: Up to 15 months ]

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