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Astellas Study ID
8951-CL-4001

A Study of Zolbetuximab Given with mFOLFOX6 or CAPOX Chemotherapy in Indian Adults with Gastric Cancer

Astellas Study ID
8951-CL-4001
Clinicaltrials.gov ID
NCT07829757
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

There is an unmet medical need to treat people with advanced cancer in the stomach and the junction area where the stomach joins the food pipe. These conditions are known as advanced or stomach (gastric) cancer and advanced gastroesophageal junction cancer (GEJ cancer for short).

Zolbetuximab is an approved treatment in many countries for people with advanced stomach cancer and advanced GEJ cancer. Some people with these cancers have a protein called Claudin 18.2 on their tumor but they do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative). Zolbetuximab works by attaching to the Claudin 18.2 protein on their tumor. This switches on the body’s immune system to attack the tumor.

In India, the standard chemotherapies used are mFOLFOX6 or CAPOX. The main aim of the study is to check the safety of zolbetuximab when given with mFOLFOX6 or CAPOX chemotherapies in people in India with advanced stomach or GEJ cancer. It will also check how well zolbetuximab controls stomach cancer and GEJ cancer when given with mFOLFOX6 or CAPOX.

Additional Study Details

Phase
Phase 4
Product
zolbetuximab
Product
Zolbetuximab
Oxaliplatin
Folinic Acid
5-fluorouracil
Capecitabine
Type
Interventional
Masking
None (Open Label)
Enrollment number
50
Show Additional Study Details

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Would you like more information about clinical trial sites that are recruiting participants for A Study of Zolbetuximab Given with mFOLFOX6 or CAPOX Chemotherapy in Indian Adults with Gastric Cancer? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • A patient advocate
  • Algeria
  • Argentina
  • Armenia
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bosnia And Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Dominican Republic
  • Egypt
  • Estonia
  • Finland
  • Former Serbia and Montenegro
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Indonesia
  • Ireland
  • Israel
  • Italy
  • Japan
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • New Zealand
  • Norway
  • Panama
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Republic of Korea
  • Republic of Moldova
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • Slovakia
  • Slovenia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Turkey
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam

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    Locations

    No locations found.
    Trial info
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    Age
    18+ years
    Diamond icon
    Condition
  • Stomach or Esophageal Cancer
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Nov 2026 - Jul 2029
    Additional Study Details
    Inclusion Criteria
    • Participant has histologically confirmed gastric or GEJ adenocarcinoma.
    • Participant has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to enrollment.
    • Participant has radiologically evaluable disease (measurable and/or non measurable) according to RECIST 1.1, per investigator assessment, ≤ 28 days prior to enrollment. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before enrollment, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.
    • Participant has ECOG performance status 0 or 1.
    • Participant has predicted life expectancy ≥ 12 weeks.
    • Female participant is not pregnant and at least 1 of the following conditions apply:
      • Not a woman of childbearing potential (WOCBP).
      • WOCBP who has a negative urine or serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study interventions.
    • Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions.
    • Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions.
    • Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final investigational study intervention administration.
    • Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final investigational study intervention administration.
    • Male participant must not donate sperm during the treatment period and for 6 months after final investigational study intervention administration.
    • The participant or legally authorized representative has provided informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and protocol.
    • Participant’s tumor expresses CLDN18.2 in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by local immunohistochemistry testing.
    • Participant has a human epidermal growth factor receptor 2 (HER2)-negative tumor as determined by local testing on a gastric or GEJ tumor specimen.
    • Participant must meet all of the criteria based on the locally analyzed laboratory tests collected within 14 days prior to enrollment. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility.
    • Participant agrees not to participate in another interventional study while receiving study intervention in the present study.
    MaximizeExclusion Criteria
    • Participant has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, mFOLFOX6 or CAPOX.
    • Participant has known dihydropyrimidine dehydrogenase (DPD) deficiency. (NOTE: Screening for DPD deficiency should be conducted per local requirements.)
    • Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.
    • Participant has significant gastric bleeding and/or untreated gastric ulcers that exclude the participant from participation.
    • Participant has a known history of a positive test for human immunodeficiency virus infection or known active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or C infection. (Note: Screening for these infections should be conducted per local requirements.)
      • For participants who are negative for HBsAg, but hepatitis B core antibody positive, an hepatitis B virus DNA test will be performed, and if positive, the participant will be excluded.
      • Participants with positive hepatitis C virus (HCV) serology but negative HCV RNA test are eligible.
      • Participants treated for HCV with undetectable viral load results are eligible.
    • Participant has an active autoimmune disease that has required systemic treatment within the past 3 months prior to enrollment.
    • Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to enrollment.
    • Participant has significant cardiovascular disease, including any of the following:
      • Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident, or hypertensive crisis within 6 months prior to enrollment;
      • History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes);
      • QT corrected (QTc) interval > 450 msec for male participants; QTc interval > 470 msec for female participants;
      • History or family history of congenital long QT syndrome;
      • Cardiac arrhythmias requiring anti-arrhythmic medications (participants with rate controlled arterial fibrillation for > 1 month prior to enrollment are eligible.)
    • Participant has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.
    • Participant has known peripheral sensory neuropathy > grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality.
    • Participant has had a major surgical procedure ≤ 28 days before enrollment and has not completely recovered from the surgical procedure ≤ 14 days before enrollment.
    • Participant has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, participant may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as it was completed at least 6 months prior to enrollment.
    • Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to enrollment and has not recovered from any related toxicity. Palliative radiotherapy is allowed and must be completed > 14 days prior to enrollment.
    • Participant has received treatment with herbal medications or other treatments that have known antitumor activity within 28 days prior to enrollment.
    • Participant has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to enrollment. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids, or receiving systemic corticosteroids as premedication for radiologic imaging contrast use is eligible.
    • Participant has received any investigational therapy within 28 days prior to enrollment.
    • Participant has any condition, which makes the participant unsuitable for study participation.
    • Participant has another malignancy for which treatment is required.
    • Participant has any concurrent disease, infection, or co-morbid condition that interferes with the ability of the participant to participate in the study, which places the participant at undue risk or complicates the interpretation of data.

    Frequently Asked Questions

    Are clinical trials only for people with advanced cancer?

    While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

    Will I have to stop my current treatment to participate in a clinical trial?

    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

    Do I need a referral from my doctor to take part in a study?

    Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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