Zolbetuximab + Chemotherapy for Gastric or Gastroesophageal Junction Cancer
(GLOW Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, zolbetuximab, combined with chemotherapy, for individuals with advanced stomach cancer or cancer where the food pipe meets the stomach (GEJ cancer). Zolbetuximab helps the immune system attack cancer by targeting a specific protein in the tumor called Claudin 18.2. Participants will receive either zolbetuximab with chemotherapy or a placebo (a look-alike with no active medicine) with chemotherapy. This trial is for adults with advanced stomach or GEJ cancer whose cancer cannot be removed by surgery and have a specific protein in their tumor. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking cancer treatment.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications. However, you cannot participate if you need to take medicines that suppress your immune system or if you have taken certain treatments with known antitumor activity within 28 days before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that zolbetuximab, when combined with chemotherapy, is generally well-tolerated by patients with stomach or gastroesophageal junction cancer. One study found that patients receiving this combination lived longer without their cancer worsening and had a longer overall survival compared to those who received a placebo with chemotherapy. This indicates that the treatment is both effective and manageable for patients.
Furthermore, the FDA has approved zolbetuximab for treating stomach or gastroesophageal junction adenocarcinoma when used with chemotherapy. This approval confirms it has been tested and found safe and effective for these cancer types.
While all treatments can have side effects, existing studies and FDA approval suggest that zolbetuximab with chemotherapy offers a promising option with a manageable safety profile for people with this type of cancer.12345Why do researchers think this study treatment might be promising for stomach or GEJ cancer?
Researchers are excited about zolbetuximab for gastric or gastroesophageal junction cancer because it offers a new approach by targeting a specific protein called Claudin 18.2, which is often found in these types of cancer cells. Unlike the standard chemotherapy options like capecitabine and oxaliplatin, zolbetuximab aims to block this protein, potentially preventing cancer growth more effectively. This targeted action might enhance the effectiveness of existing treatments and improve outcomes for patients with this challenging condition.
What evidence suggests that zolbetuximab combined with chemotherapy could be an effective treatment for gastric or GEJ cancer?
This trial will compare the combination of zolbetuximab with chemotherapy to a placebo with chemotherapy for individuals with stomach or gastroesophageal junction (GEJ) cancer. Studies have shown that combining zolbetuximab with chemotherapy extends the time patients live without their cancer worsening. Research indicates that this combination improves progression-free survival, meaning more time without cancer growth, and overall survival compared to chemotherapy alone. Zolbetuximab targets a protein called Claudin 18.2, found in many stomach and GEJ cancers, aiding the immune system in attacking cancer cells. Patients whose tumors contain this protein have benefited from this treatment. This treatment has received approval in some countries, demonstrating its effectiveness in treating these cancer types.25678
Who Is on the Research Team?
Medical Director
Principal Investigator
Astellas Pharma Global Development
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zolbetuximab or placebo with CAPOX chemotherapy in 3-week cycles for up to 6 months
Extended Treatment
Participants may continue to receive capecitabine chemotherapy until disease progression or intolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment, with scans every 9 or 12 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Capecitabine
- Oxaliplatin
- Placebo
- Zolbetuximab
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available