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New targeted therapy aims to extend life in stomach cancer

NCT ID NCT06649292

Disease control Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests a new drug, SHR-A1904, in 524 people with advanced stomach or gastroesophageal junction cancer that has a specific protein (CLDN18.2). Participants receive either SHR-A1904 or standard chemotherapy. The main goal is to see if the new drug helps people live longer. The study is currently recruiting.

What this could mean

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

Active substance
SHR-A1904 (an antibody-drug conjugate targeting CLDN18.2)
What this could lead to
If successful, this could provide a new targeted treatment option for people with advanced gastric cancer whose tumors have a specific marker (CLDN18.2).
What could go wrong
This is a Phase 3 trial, but the drug is still experimental. It may not improve survival compared to current chemotherapies, and side effects from the targeted therapy could be significant.

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 524 people

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

Started

Nov 2024

Expected to finish

Mar 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 to 75 years

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. Age 18 to 75 years old (including boundary values) 2. Volunteer to participate in this clinical study and sign informed consent; 3. ECOG score 0-1; 4. Expected survival ≥3 months; 5. Gastric or Gastroesophageal Junction Adenocarcinoma; 6. positive CLDN18.2 expression in tumor tissue; 7. There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria; 8. Adequate bone marrow and organ function. Exclusion Criteria: 1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study 2. HER2 posotive (IHC 3+ or IHC 2+/ISH +); 3. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1; 4. Individuals with Leptomeningeal metastasis or Active brain metastases; 5. Individuals with a history of GI perforation or fistula, unstable GI bleeding; 6. Individuals with a history of severe cardiovascular and cerebrovascular diseases; 7. The researcher determined that there are other situations that are not suitable for participation.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Second-line advanced or metastatic gastric or gastroesophageal junction adenocarcinoma

How to take part

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

  1. The places running it

    1 site. 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

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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