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NCT03653507 · OUTCOME

Number of Anti-drug Antibody (ADA) Positive Participants

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Predose on C1D1,C2D1,C5D1,C9D1,C13D1,C17D1, 30-day follow up, 90-day Follow up

What was measured

Immunogenicity will be measured by the number of participants that are ADA positive.

Analysis population: Participants who were Randomized to Zolbetuximab + CAPOX Arm with at least One Valid Result for ADA

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+ Zolbetuximab249

Reported measurements

C1D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab249
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab4Not reportedNot reportedNot reportedNot reported
C2D2

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab212
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab8Not reportedNot reportedNot reportedNot reported
C5D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab159
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab2Not reportedNot reportedNot reportedNot reported
C9D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab92
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab1Not reportedNot reportedNot reportedNot reported
C13D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab54
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab0Not reportedNot reportedNot reportedNot reported
C17D1

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab38
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab0Not reportedNot reportedNot reportedNot reported
30 Day follow up

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab64
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab5Not reportedNot reportedNot reportedNot reported
90 Day follow up

Analysis denominator · Participants

GroupSource count
CAPOX+ Zolbetuximab46
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CAPOX+ Zolbetuximab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        249
      units
      Participants
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        212
      units
      Participants
    title
    C2D2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      units
      Participants
    title
    C5D1
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      units
      Participants
    title
    C9D1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    C13D1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      units
      Participants
    title
    C17D1
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      units
      Participants
    title
    30 Day follow up
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      units
      Participants
    title
    90 Day follow up
denoms
  1. counts
    1. group Id
      OG000
      value
      249
    units
    Participants
description
Immunogenicity will be measured by the number of participants that are ADA positive.
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
NUMBER
population Description
Participants who were Randomized to Zolbetuximab + CAPOX Arm with at least One Valid Result for ADA
reporting Status
POSTED
time Frame
Predose on C1D1,C2D1,C5D1,C9D1,C13D1,C17D1, 30-day follow up, 90-day Follow up
title
Number of Anti-drug Antibody (ADA) Positive Participants
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice