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NCT03504397 · OUTCOME

Number of Participants With Anti-drug Antibodies (ADA)

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. · Source last updated 2026-05-04

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, C1D22, C3D1, C5D1, C7D1, C9D1, 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 + mFOLFOX6 Arm with at least One Valid Result for ADA.

Groups in this outcome

mFOLFOX6 + Zolbetuximab

Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.

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

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab283

Reported measurements

C1D1

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab265
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab2Not reportedNot reportedNot reportedNot reported
C1D22

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab182
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab2Not reportedNot reportedNot reportedNot reported
C3D1

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab189
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab3Not reportedNot reportedNot reportedNot reported
C5D1

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab139
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab2Not reportedNot reportedNot reportedNot reported
C7D1

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab101
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab2Not reportedNot reportedNot reportedNot reported
C9D1

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab1Not reportedNot reportedNot reportedNot reported
30 day follow up

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab85
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab4Not reportedNot reportedNot reportedNot reported
90 day follow up

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab76
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        265
      units
      Participants
    title
    C1D1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        182
      units
      Participants
    title
    C1D22
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        189
      units
      Participants
    title
    C3D1
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        139
      units
      Participants
    title
    C5D1
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        101
      units
      Participants
    title
    C7D1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    C9D1
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      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
        76
      units
      Participants
    title
    90 day follow up
denoms
  1. counts
    1. group Id
      OG000
      value
      283
    units
    Participants
description
Immunogenicity will be measured by the number of participants that are ADA positive.
groups
  1. description
    Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
    id
    OG000
    title
    mFOLFOX6 + Zolbetuximab
param Type
NUMBER
population Description
Participants who were randomized to zolbetuximab + mFOLFOX6 Arm with at least One Valid Result for ADA.
reporting Status
POSTED
time Frame
Predose on C1D1, C1D22, C3D1, C5D1, C7D1, C9D1, 30-day follow up, 90-day follow up
title
Number of Participants With Anti-drug Antibodies (ADA)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice