Experimental combo targets Hard-to-Treat stomach cancer
NCT ID NCT04768686
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
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May 2021
- Finished
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Aug 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Asan Medical Center
Seoul, South Korea
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Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
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Gangnam Severance Hospital
Seoul, South Korea
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Hanllym University Medical Center
Anyang-si, Gyeonggi-do, South Korea
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Korea University Guro Hospital
Seoul, South Korea
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Samsung Medical Center
Seoul, South Korea
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
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Seoul National University Hospital
Seoul, South Korea
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Severance Hospital
Seoul, South Korea
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The Catholic University of Korea St. Vincent Hospital
Suwon, Gyeonggi-do, South Korea
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Other studies related to the condition(s) this trial covers.
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- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Engineered immune cells target two markers on Hard-to-Treat tumors