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New drug cocktail targets Hard-to-Treat stomach cancer

NCT ID NCT07102901

Disease control Sponsor: Jiangsu HengRui Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 2 trial is testing whether a new targeted drug called SHR2554, taken as a tablet, can be safely combined with other anti-cancer injections to treat advanced stomach or gastroesophageal junction cancer. The study will enroll 351 adults whose cancer has spread or cannot be removed by surgery. Researchers will monitor side effects and measure how well the tumors shrink or stop growing.

What this could mean

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

Active substance
SHR2554 tablets (a targeted cancer drug) combined with other anti-tumor injections (SHR-A1811, SHR-A1904, SHR-1701)
What this could lead to
If successful, this could provide a new treatment option for people with advanced gastric cancer that has stopped responding to standard therapies.
What could go wrong
This is an early Phase 2 trial, so the combination may not work better than existing treatments. Side effects from the drug combinations could be serious or hard to manage.

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 351 people

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

Started

Sep 2025

Expected to finish

Dec 2027

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. At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed. 2. Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening. 3. Is willing to provide an adequate tumor sample. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening. Exclusion Criteria: 1. Presence of dysphagia or other factors impairing oral administration of SHR2554. 2. Has previously been treated with any enhancer of zeste homolog inhibitors. 3. Uncontrolled or significant cardiovascular disease. 4. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. 5. Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants. 6. History of known hypersensitivity to SHR2554 or excipients. 7. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals. 8. Diagnosis of other malignancies within 5 years prior to the first dose of investigational product. 9. Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history. 10. Psychological, social, familial, or geographical factors that would prevent regular follow-up.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric carcinoma gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Advanced gastric cancer Gastroesophageal junction adenocarcinoma Metastatic gastric 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

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150081, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

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