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New hope for stomach cancer: targeted combo therapy enters final trial phase

NCT ID NCT06206733

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 2 times

Summary

This study tests a new drug called ASKB589 combined with chemotherapy and an immunotherapy for people with advanced stomach or gastroesophageal junction cancer that has spread. The trial includes 780 participants whose tumors have a specific marker (CLDN18.2). The goal is to see if the combination helps delay cancer growth or improve survival compared to standard treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 780 people

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

Started

Jan 2024

Expected to finish

Dec 2028

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.

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 adenocarcinoma of gastric and gastroesophageal junction 2. Advanced recurrent or metastatic disease confirmed by imaging within 28 days prior to randomization 3. Suitable for chemotherapy combined with PD-1 inhibitor 4. Not suitable for anti-HER2 therapy 5. Have at least one measurable lesion according to RECIST1.1 assessed by site investigator within 28 days prior to randomization 6. CLDN 18.2 positive Exclusion Criteria: 1. Patients with active central nervous system (CNS) metastases or suspected carcinomatous meningitis 2. Participants have significant gastric bleeding 3. The presence of clinically uncontrollable third interspace fluid 4. Received anti-CLDN18.2 antibody at any time in the past 5. Suspected complete or partial obstruction of gastroesophageal access

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Beijing cancer hospital

    Beijing, China

More trials for these conditions

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