Phase 2 Stomach Cancer Trial, Recruiting NCT06962137 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT06962137
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be at least 18 years old when you sign the consent form
  • You must be fairly active and able to carry out daily activities with little or no limitation (this is measured by a standard scale called WHO performance status 0–1 — confirm with trial site if unsure)
  • You must have been diagnosed with a type of stomach or esophageal cancer called adenocarcinoma that has spread to other parts of the body, confirmed by a tissue sample (biopsy)
  • You must have already received one standard course of treatment (first-line therapy) for this cancer, which may or may not have included immunotherapy
  • If your cancer came back during or within 6 months of finishing a post-surgery treatment (adjuvant therapy), that treatment counts as your first-line therapy
  • Your cancer cells must test positive for a protein called CLDN18.2, found in a high proportion of your tumour cells, based on a specific laboratory test
  • Any PDL1 test result is acceptable — you do not need a specific score
  • If you are able to have children, you must be willing to use highly effective birth control during the trial
  • You must be willing and able to give written consent to take part in the trial

Who may not be able to join:

  • You have a type of esophageal cancer called squamous cell cancer that has spread
  • You have a medical reason why you cannot receive a type of drug that targets blood vessel growth (anti-VEGF), such as a recent stroke, heart attack, active blood clot in an artery, a hole in your bowel or stomach, significant protein in your urine, or an open wound that is not healing
  • You currently have another active cancer
  • You have previously been treated with Zolbetuximab or any other treatment that directly targets the CLDN18.2 protein as a first-line therapy
  • You have a known allergy or severe reaction to Zolbetuximab or any of its ingredients (confirm with trial site for full ingredient list)
  • You are pregnant, breastfeeding, planning to become pregnant, or are able to become pregnant and are not using a highly effective form of contraception
  • You are currently taking part in another clinical trial involving an experimental medicine or medical device

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Filip Van Herpe, MD, Universitaire Ziekenhuizen KU Leuven

Phone: +32 16 34 42 18

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
11 December 2025
Est. completion
31 December 2029

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

OS (overall survival)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov