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New drug duo aims to wipe out stomach cancer before surgery

NCT ID NCT07477444

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests whether adding two targeted drugs (zanidatamab and tislelizumab) to standard chemotherapy can completely eliminate HER2-positive gastroesophageal cancer before surgery. About 29 adults with operable, locally advanced disease will receive the combination before and after tumor removal. The main goals are safety and seeing if the cancer disappears entirely in the removed tissue.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 29 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2033

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: * Voluntary written informed consent from the participant or their legally authorized representative * At least 18 years of age at the time of signing the consent form * Agreement to use highly effective birth control methods for both male and female patients * WHO-ECOG performance status of 0 or 1 * Histologically proven HER2-positive gastroesophageal, esophageal, or gastric adenocarcinoma * Localized, resectable disease that is fit for perioperative treatment, including surgery * Adequate hepatic function * Adequate renal function with an estimated Glomerular Filtration Rate (GFR) \> 50 mL/min * Adequate hematologic function * Cardiac ejection fraction Exclusion Criteria: * Prior neoadjuvant or definitive chemoradiation * Squamous cell cancer of the esophagus * Metastatic or unresectable gastroesophageal cancer * Active or relapsing autoimmune diseases, with exceptions for controlled Type 1 diabetes, hypothyroidism (hormone replacement only), controlled celiac disease, or certain skin diseases not requiring systemic treatment * Known hypersensitivity to zanidatamab, tislelizumab, or any of their excipients * Known Dihydropyrimidine Dehydrogenase (DPD) deficiency * Active infections requiring systemic treatment * History of significant cardiac disease * Previous malignancy within the last 5 years * Current participation in another interventional Trial involving an investigational medicinal product or device

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Conditions

The condition(s) this trial relates to.

gastroesophageal adenocarcinoma gastroesophageal cancer

As listed by the trial registrant

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

Gastroesophageal cancer

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.