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New drug combo aims to shrink advanced stomach tumors

NCT ID NCT07609667

Disease control Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new drug combination (SKB315 plus an immunotherapy) in people with advanced stomach or gastroesophageal junction cancer that cannot be removed by surgery. About 80 participants in China will receive the treatment to see if it shrinks tumors. The goal is to control the disease, not cure it, as ongoing treatment is needed.

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 80 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 2029

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 80 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. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma 2. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. 3. Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC; 4. Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; 5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; 6. Estimated survival ≥ 3 months as judged by the investigator; 7. Adequate organ and bone marrow function (no blood components and cytokines are allowed within 2 weeks prior to the first dose) ; 8. Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing; Exclusion Criteria: 1. Active leptomeningeal disease or uncontrolled brain metastasis 2. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2 3. Received other drugs in clinical study, major surgeries, or any other antitumor therapies within 4 weeks prior to the first dose of study treatment; 4. Patients with active hepatitis B or hepatitis C; 5. Patients have significant gastric bleeding 6. The presence of clinically uncontrollable third interspace fluid 7. Have clinically significant systemic diseases that may adversely affect the safety of the study; 8. Patients who may have poor compliance with the clinical study or have other factors based on which the investigator considers that the patients are not appropriate to patients in the study.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

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

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

More trials for these conditions

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