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Can a targeted therapy tame hard-to-treat stomach and esophageal cancers?

NCT ID NCT07780968

Disease control Sponsor: Jazz Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study looks at how zanidatamab, a targeted drug for HER2-positive gastroesophageal cancer, is used in real-world clinical practice. Researchers will track about 300 adults with advanced or metastatic disease who are starting zanidatamab as their first treatment, recording patient characteristics, treatment patterns, side effects, and outcomes. The goal is to understand how effective and tolerable the drug is outside of clinical trials, helping guide future treatment decisions.

What this could mean

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

Active substance
zanidatamab (also known as ZW25, JZP598, ZIIHERA®), given by intravenous infusion
What this could lead to
If this study shows zanidatamab works well and is well-tolerated in everyday practice, it could support its broader use as a first-line treatment for HER2-positive gastroesophageal cancer.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient differences and real-world variability, and the drug may still have side effects like diarrhea.

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.

Participants

About 300 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study will enroll approximately 300 male and female participants, aged 18 years or older in the United States, diagnosed with HER2-positive locally advanced or metastatic GEA with a plan to initiate a 1L zanidatamab-containing therapy.

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. Histologically confirmed HER2-positive (defined as IHC3+ or IHC2+ with ISH positivity) locally advanced or metastatic GEA 2. Documented plan to initiate a zanidatamab-containing therapy as 1L treatment 3. Sufficient cognitive capacity and language proficiency to complete patient-reported outcomes (PRO) questions 4. 18 years of age or older on the date of initiating 1L zanidatamab-containing therapy Exclusion criteria: 1. Receiving a zanidatamab-containing therapy as part of a clinical trial or expanded access program 2. Received zanidatamab prior to the approval date by the FDA for HER2+ la/m GEA 3. Received the first infusion of zanidatamab prior to providing study consent 4. For patients initiating chemotherapy backbone first, more than 2 months have elapsed before the first dose of zanidatamab

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Conditions

The condition(s) this trial relates to.

esophageal cancer Esophageal Neoplasms gastric cancer gastric neoplasm gastroesophageal adenocarcinoma gastroesophageal cancer

As listed by the trial registrant

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

Esophageal cancer Gastroesophageal cancer Gastroesophageal junction cancer HER2-positive gastric cancer Stomach cancer

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • UCI Health - Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • University of Texas - MD Anderson Cancer Center Gastrointestinal Cancer Center

    Houston, Texas, 77030, United States

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