New drug combo shows promise for tough stomach cancer
NCT ID NCT05419362
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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42 people
The number who actually took part.
- Started
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Apr 2022
- 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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19 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: * 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
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Ajou University Hospital
Gyeonggi-do, South Korea
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Asan Medical Center
Seoul, South Korea
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Samsung Medical Center
Seoul, South Korea
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Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
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Yonsei University Health System, Severance Hospital
Seoul, South Korea
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