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Chemotherapy
Zolbetuximab + Chemotherapy for Gastric or Gastroesophageal Junction Cancer (GLOW Trial)
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 23 months
Awards & highlights
GLOW 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).
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.
GLOW Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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).
GLOW Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 23 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
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 moreGLOW 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
zolbetuximab
2019
Completed Phase 2
~270
oxaliplatin
2002
Completed Phase 3
~6370
capecitabine
2002
Completed Phase 3
~2360
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,579 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development
2,777 Previous Clinical Trials
8,063,233 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by scans and was checked within the last 28 days.My tumor shows high CLDN18.2 expression.I have not taken strong immune system suppressing drugs in the last 14 days, except for low-dose steroids or a one-time dose.You have a known allergy or intolerance to any part of the study treatment.I am severely allergic to zolbetuximab or similar drugs.I do not have significant gastric bleeding or untreated ulcers.I do not have active hepatitis B according to my test results.My cancer is advanced and cannot be removed by surgery, confirmed by scans within the last 28 days.My stomach cancer is not HER2 positive.I am fully active or restricted in physically strenuous activity but can do light work.My hemoglobin level is at least 9 g/dL, even if I needed a transfusion to reach this.I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.I or my family have a history of long QT syndrome.I haven't had serious heart issues or strokes in the last 6 months.I've had chemotherapy for advanced stomach cancer but finished it 6+ months ago.I had radiotherapy for stomach cancer less than 14 days ago and still have side effects.I have not used herbal medications or treatments with cancer-fighting properties in the last 28 days.I agree not to donate sperm during and for 6 months after the study.I was treated for hepatitis C and now have no detectable virus.I agree to follow birth control advice during and after treatment as required.My liver function tests are within the required range.I have serious heart problems.I have a history of serious heart rhythm problems.My cancer has spread to my brain or its coverings from my stomach or gastroesophageal junction.I do not have severe nerve damage in my hands or feet.I need treatment for another type of cancer.I agree not to breastfeed during and for 6 months after the study.I will not donate eggs during and for 9 months after the study if I receive oxaliplatin, or 6 months for other drugs.I am a man and my partner can become pregnant.I take medication for an irregular heartbeat, but it's been stable for over a month.I have had a severe allergic reaction to CAPOX components.I had major surgery less than 28 days ago.I have not fully recovered from a major surgery within the last 2 weeks.I have been diagnosed with stomach or GEJ cancer.I have a known DPD deficiency.I have severe blockage in my stomach causing vomiting.I have an infection needing treatment that hasn't cleared in the last week.I have an autoimmune disease treated within the last 3 months.I am not pregnant and meet one of the specific conditions for the study.My bilirubin levels are within the normal range, or slightly higher if I have liver metastases.My kidneys are functioning well enough (creatinine clearance ≥ 30 mL/min).
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (Placebo plus CAPOX)
- Group 2: Arm A (zolbetuximab plus CAPOX)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For what reason is zolbetuximab most commonly prescribed?
"zolbetuximab is indicated for the treatment of metastatic colorectal carcinoma as well as other conditions like pancreatic endocrine carcinoma, stage iii colon cancer, and refractory ovarian cancer."
Answered by AI
Does zolbetuximab have a solid research pedigree?
"Zolbetuximab is currently being investigated in 584 live clinical trials, with 197 of those trials in Phase 3. The majority of the clinical trials for zolbetuximab are taking place in Woolloongabba, Queensland, but there are 21855 total locations running clinical trials for zolbetuximab."
Answered by AI
Does zolbetuximab have a clean bill of health?
"Zolbetuximab's safety is relatively well-known due to its status as a Phase 3 drug, thus it was given a score of 3."
Answered by AI
Are there different branches of this research being conducted in North America?
"Thirteen locations across the world are enrolling patients for this study, including Site CA15004 in Calgary, Greenville Health System Cancer Center in Greenville, and Prisma Health Cancer Institute in Boiling Springs."
Answered by AI
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