Participant flow

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.

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 days.

   id

   FG000

   title

   CAPOX+ Zolbetuximab

2. description

   Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C2D1 until participant met study treatment discontinuation criteria. Participants also received up to 8 treatments of CAPOX. 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 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 days.

   id

   FG001

   title

   CAPOX+ Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         19

      type

      Miscellaneous

   2. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         22

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Deviation

   4. reasons

      1. group Id

         FG000

         num Subjects

         117

      2. group Id

         FG001

         num Subjects

         168

      type

      Progressive disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         22

      type

      Death

   7. reasons

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         14

      type

      Adverse Event

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         254

      2. group Id

         FG001

         num Subjects

         249

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         2

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         245

      2. group Id

         FG001

         num Subjects

         247

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. Randomization was stratified by region (Asia vs Non-Asia), number of organs with metastatic sites (0 to 2 vs ≥ 3) and prior gastrectomy (Yes or No)

recruitment Details

Participants with claudin (CLDN)18.2-positive, human epidermal growth factor receptor 2 (HER2) -negative locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma

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Preserved source evidence · Not medical advice