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Chemotherapy

Zolbetuximab + Chemotherapy for Gastric or Gastroesophageal Junction Cancer (GLOW Trial)

Daegu, Korea, Republic of
Phase 3
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject's tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central IHC testing.
Subject has a HER2-negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen.
Must not have
Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies.
Subject has significant gastric bleeding and/or untreated gastric ulcers that exclude the subject from participation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 23 months
Awards & highlights
Pivotal Trial

Summary

This trial will compare the effects of a new drug (zolbetuximab) on cancer progression, safety, and quality of life, compared to the standard treatment (placebo plus CAPOX).

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Who is the study for?
This trial is for adults with advanced gastric or gastroesophageal junction adenocarcinoma that tests positive for CLDN18.2 and negative for HER2. Participants must have a life expectancy of at least 12 weeks, acceptable organ function, and agree to contraception if applicable. Those who've had recent immunosuppressive therapy, other clinical trials, severe allergies to study drugs, active infections requiring systemic therapy, significant cardiovascular disease or another malignancy needing treatment are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of zolbetuximab combined with CAPOX (capecitabine and oxaliplatin) versus a placebo plus CAPOX as first-line treatment by measuring how long patients live without their cancer getting worse. It will also assess physical function impacts, safety profiles including side effects, quality of life changes due to the drug regimen and study the body's response to zolbetuximab.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion such as fever or chills; digestive issues like nausea or diarrhea from chemotherapy; blood-related problems such as low white cell counts increasing infection risk; fatigue; liver enzyme alterations; potential bleeding complications; nerve damage manifesting as tingling or numbness in extremities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor shows high CLDN18.2 expression.
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My stomach cancer is not HER2 positive.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I agree not to breastfeed during and for 6 months after the study.
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I am a man and my partner can become pregnant.
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My liver function tests are within the required range.
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I have been diagnosed with stomach or GEJ cancer.
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My bilirubin levels are within the normal range, or slightly higher if I have liver metastases.
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My kidneys are functioning well enough (creatinine clearance ≥ 30 mL/min).
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am severely allergic to zolbetuximab or similar drugs.
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I do not have significant gastric bleeding or untreated ulcers.
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I do not have active hepatitis B according to my test results.
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I or my family have a history of long QT syndrome.
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I haven't had serious heart issues or strokes in the last 6 months.
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I was treated for hepatitis C and now have no detectable virus.
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I have serious heart problems.
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I have a history of serious heart rhythm problems.
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My cancer has spread to my brain or its coverings from my stomach or gastroesophageal junction.
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I need treatment for another type of cancer.
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I have had a severe allergic reaction to CAPOX components.
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I have not fully recovered from a major surgery within the last 2 weeks.
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I have a known DPD deficiency.
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I have severe blockage in my stomach causing vomiting.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 23 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Duration Of Response (DOR)
Health Related Quality of Life (HRQoL) measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire
Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Oesophago-Gastric Module 25 (QLQ-OG25) questionnaire plus EORTC-QLQ-STO22 Belching subscale
+12 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (zolbetuximab plus CAPOX)Experimental Treatment3 Interventions
Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive CAPOX (capecitabine/oxaliplatin) treatment until IRC confirmed disease progression or a total of 8 treatments (each cycle is defined as 3 weeks = approximately 21 days). Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14. After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive capecitabine twice daily on days 1 through 14 of each cycle at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Group II: Arm B (Placebo plus CAPOX)Placebo Group3 Interventions
Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive CAPOX (capecitabine/oxaliplatin) treatment until IRC confirmed disease progression or a total of 8 treatments (each cycle is defined as 3 weeks = approximately 21 days). Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14. After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive capecitabine twice daily on days 1 through 14 of each cycle at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
capecitabine
2002
Completed Phase 3
~2360
zolbetuximab
2019
Completed Phase 2
~270
oxaliplatin
2002
Completed Phase 3
~6370

Find a Location

Closest Location:University of Kansas Cancer Center and Medical Pavilion· Fairway, KS

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
200 Previous Clinical Trials
121,677 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development
2,905 Previous Clinical Trials
8,090,982 Total Patients Enrolled

Media Library

Capecitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03653507 — Phase 3
Stomach Cancer Research Study Groups: Arm B (Placebo plus CAPOX), Arm A (zolbetuximab plus CAPOX)
Stomach Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT03653507 — Phase 3
Capecitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03653507 — Phase 3
~72 spots leftby Jan 2026