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NCT03653507 · OUTCOME

Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW). · Source last updated 2026-07-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
micrograms/mililiter (ug/mL)
Interval / dispersion
Standard Deviation
Time frame
Predose on C2D1,C5D1,C9D1,C13D1,C17D1

What was measured

Ctrough was defined as the predose concentration at the end of dosing interval.

Analysis population: Pharmakokinetic analysis set (PKAS) consisted of the subset of the SAF for which at least 1 zolbetuximab concentration measurement was available. Participants with available data at each timepoint were analyzed.

Groups in this outcome

CAPOX+ Zolbetuximab

Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab217

Reported measurements

C2D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab217
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab38.631.3Not reportedNot reportedNot reported
C5D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab160
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab74.151.6Not reportedNot reportedNot reported
C9D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab92
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab99.658.2Not reportedNot reportedNot reported
C13D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab52
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab119.055.6Not reportedNot reportedNot reported
C17D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab37
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab147.070.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.3
        value
        38.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        217
      units
      Participants
    title
    C2D1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.6
        value
        74.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        160
      units
      Participants
    title
    C5D1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.2
        value
        99.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      units
      Participants
    title
    C9D1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.6
        value
        119.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    C13D1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        70.5
        value
        147.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    C17D1
denoms
  1. counts
    1. group Id
      OG000
      value
      217
    units
    Participants
description
Ctrough was defined as the predose concentration at the end of dosing interval.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received an intravenous (IV) infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle 1 day 1 (C1D1) followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of capecitabine and oxaliplatin (CAPOX) treatment. Oxaliplatin was administered 130 mg/m\^2 IV on day 1 of each cycle over 2 hours for a maximum of 8 treatments; Capecitabine was administered orally at 1000 mg/m\^2 twice daily (bid) on days 1 through 14 of each cycle until the participant met study treatment discontinuation criteria. After a maximum of 8 treatments of oxaliplatin, participants may have continued to receive capecitabine taken twice daily on days 1 through 14 of each cycle at the investigator's discretion until the participant met study treatment discontinuation criteria. Each cycle was approximately 21
    id
    OG000
    title
    CAPOX+ Zolbetuximab
param Type
MEAN
population Description
Pharmakokinetic analysis set (PKAS) consisted of the subset of the SAF for which at least 1 zolbetuximab concentration measurement was available. Participants with available data at each timepoint were analyzed.
reporting Status
POSTED
time Frame
Predose on C2D1,C5D1,C9D1,C13D1,C17D1
title
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
type
SECONDARY
unit Of Measure
micrograms/mililiter (ug/mL)

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Preserved source evidence · Not medical advice