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Experimental combo targets Hard-to-Treat stomach cancer

NCT ID NCT04768686

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 study tested a new drug, FLX475, combined with the immunotherapy pembrolizumab (Keytruda) in 20 people with advanced or metastatic stomach cancer. The goal was to see if the combination could shrink tumors in patients who had already tried other treatments. The study included two groups based on whether the cancer was linked to the Epstein-Barr virus.

What this could mean

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

Active substance
FLX475 (tablet) and pembrolizumab (IV infusion)
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced gastric cancer who have run out of standard therapies.
What could go wrong
This is a small, early-phase study with only 20 participants enrolled. The results may not apply to all patients, and the combination may cause side effects or fail to shrink tumors.

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

20 people

The number who actually took part.

Started

May 2021

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

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: * All patients must have histologically or cytologically confirmed, advanced, relapsed or metastatic gastric or gastroesophageal junction adenocarcinoma * Patient must have one of the following diagnoses to be eligible for enrollment into cohorts: * Cohort 1: Checkpoint inhibitor naïve Epstein-Barr Virus negative (EBV-) gastric cancer patient who has had a disease progression after at least 2 prior systemic treatments for advanced or metastatic gastric cancer * Cohort 2: Checkpoint inhibitor naïve Epstein-Barr virus positive (EBV+) gastric cancer patient (as determined by standard methods, e.g. EBER ISH or LMP-1 IHC) who had at least 1 prior systemic treatment for advanced or metastatic gastric cancer * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Patient must have at least one measurable lesion at baseline by computed tomography(CT) or magnetic resonance imaging (MRI) * Tumor available for biopsy Exclusion Criteria: * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), any history of discontinuing from that treatment due to Grade 3 or higher immune-related adverse event (irAE) * Patient with MSI-H status * Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or clinical symptoms of active pneumonitis * Significant cardiovascular disease. New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or chronic Grade 3 hypertension. * Significant screening electrocardiogram (ECG) abnormalities * Has had an allogenic tissue/solid organ transplant

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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

  • Asan Medical Center

    Seoul, South Korea

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, South Korea

  • Gangnam Severance Hospital

    Seoul, South Korea

  • Hanllym University Medical Center

    Anyang-si, Gyeonggi-do, South Korea

  • Korea University Guro Hospital

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital

    Seoul, South Korea

  • The Catholic University of Korea St. Vincent Hospital

    Suwon, Gyeonggi-do, South Korea

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