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New drug combo targets stomach cancer protein in 100-Patient trial

NCT ID NCT06962137

Disease control Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding the targeted drug zolbetuximab to standard chemotherapy (paclitaxel and ramucirumab) can help people with advanced stomach or gastroesophageal cancer live longer. It includes 100 adults whose tumors have a specific protein called CLDN18.2. Participants receive the drug combination as a second treatment after first-line therapy has stopped working.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zolbetuximab (a targeted antibody) plus paclitaxel and ramucirumab (chemotherapy drugs)
What this could lead to
If it works, this could offer a more effective second-line treatment option for people with a specific type of stomach cancer.
What could go wrong
This is a Phase 2 trial with only 100 participants, so results are preliminary. The added drug may cause more side effects and might not improve survival compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. At least 18 years of age at the time of ICF 2. WHO performance status 0 - 1 3. Histologically proven metastatic gastroesophageal adenocarcinoma 4. Pretreatment with one 1st line therapy according to SOC (+/- immunotherapy) 5. If relapse while adjuvant (immune/chemo) therapy or within 6 months ending adjuvant therapy the adjuvant therapy is considered a first line therapy 6. CLDN18.2-positive (defined as ≥75% of tumour cells showing moderate-to-strong membranous CLDN18.2 staining, as determined by immunohistochemistry using the VENTANA CLDN18 \[43-14A\] RxDx Assay. 7. Any PDL1 score 8. Use of highly effective methods of birth control 9. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. Exclusion Criteria: \- 1. Metastatic squamous cell cancer of the esophagus 2. Absolute contra-indication for anti-VEGF inhibitors (tumor perforation, active proteinuria, recent stroke, myocardial infarction, acute arterial thrombosis, active wound problem) 3. Other active malignancy 4. Pretreatment with Zolbetuximab or other anti-CLDN18.2 direct therapy in first line setting once available. 5\. Known hypersensitivity to the active substance Zolbetuximab or to any of the excipients \[(Arginine, Phosphoric acid (E 338), Sucrose, Polysorbate 80 (E 433)\] 6. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive 7. Participation in another interventional Trial with an investigational medicinal product (IMP) or device

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric adenocarcinoma and gastroesophageal junction adenocarcinoma Gastric cancer adenocarcinoma metastatic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Delta Roeselare

    NOT_YET_RECRUITING

    Roeselare, Belgium

  • Cliniques Universitaires Saint-Luc Brussels

    NOT_YET_RECRUITING

    Brussels, Belgium

  • HUB

    NOT_YET_RECRUITING

    Brussels, Belgium

  • UZ Gent

    NOT_YET_RECRUITING

    Ghent, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • UZA

    NOT_YET_RECRUITING

    Antwerp, Belgium

    Contact Email: •••••@•••••

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