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New drug combo shows promise for tough stomach cancer

NCT ID NCT05419362

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new treatment combination (GEN-001 plus avelumab) in 42 people with advanced stomach or gastroesophageal junction cancer that had not responded to at least two prior therapies. All participants had a specific marker (PD-L1 positive) on their tumors. The goal was to see if the combination could shrink tumors and how safe it was. This was a phase II trial, meaning it was an early test of effectiveness and safety.

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

42 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2024

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

19 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: * Histologically confirmed unresectable, recurrent, locally advanced or metastatic GC/Gastroesophageal Junction Adenocarcinoma * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have adequate organ functions as defined in the protocol * Negative childbearing potential * Have experienced documented objective radiographic or clinical disease progression after 2 or above previous lines of standard therapy. * PD-L1 positive * Measurable disease as per RECIST v1.1 defined as at least 1 lesion * Estimated life expectancy of at least 3 months * Have ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities Exclusion Criteria: * Previously received T-cell coregulatory protein inhibitors * Has clinically significant evidence of ascites by physical exam * Known prior severe hypersensitivity reactions to monoclonal antibodies or any component in their formulation * Has active autoimmune disease that has required systemic treatment in the past 2 years * Current use of immunosuppressive medication * Have an active infection requiring antibiotics, antifungal or antiviral agents or have received a course of antibiotics within 4 weeks * Has received a live vaccine within 4 weeks * Known history or any evidence of active for non-infectious pneumonitis * Prior solid organ or allogeneic stem cell transplantation * Has had any investigational or anti-tumor treatment within 4 weeks or 5 half-life periods of starting study treatment, had any major surgeries within 4 weeks * Has received proton pump inhibitors (PPIs) within 2 weeks * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has clinically significant (i.e., active) cardiovascular disease * Has other persisting toxicities * Has other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, or psychiatric conditions

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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

  • Ajou University Hospital

    Gyeonggi-do, South Korea

  • Asan Medical Center

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Gyeonggi-do, South Korea

  • Yonsei University Health System, Severance Hospital

    Seoul, South Korea

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