Gastric CancerPhase 2NCT05419362
GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer
A Phase 2 study testing GEN-001 and Avelumab in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Genome & Company at 5 sites in South Korea.
Trial summary
This is a phase II, multicenter, open-label study to evaluate the antitumor activity, efficacy and safety of GEN-001 in combination with avelumab as a third line (3L) or greater line treatment which is not received the Standard of Care (SOC) for patients with PD-L1 positive advanced GC/Gastroesophageal Junction… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- GEN-001 and Avelumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 7 Apr 2022to 26 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Ajou University Hospital
Gyeonggi-do
Seoul National University Bundang Hospital
Gyeonggi-do
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: A Phase II Study to Evaluate the Safety and the Efficacy of GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This is a phase II, multicenter, open-label study to evaluate the antitumor activity, efficacy and safety of GEN-001 in combination with avelumab as a third line (3L) or greater line treatment which is not received the Standard of Care (SOC) for patients with PD-L1 positive advanced GC/Gastroesophageal Junction Adenocarcinoma who are not received cancer immunotherapy regimens as mono or combination therapy.
- Being tested
- GEN-001, Avelumab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN-001Drug
The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10^11 colony-forming units (CFU)
AvelumabDrug
Also called Bavencio
800 mg given by intravenous (IV) infusion once every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| GEN-001 with avelumab | Experimental | 42 patients in total with metastatic GC/Gastroesophageal Junction Adenocarcinoma who have progressed after 2 prior systemic treatments and confirmed PD-L1 positive expression will be enrolled in this study. Receives: Drug: GEN-001; Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: 1 years
Secondary outcomes (5)
Incidence of Adverse Events
Assessed as per CTCAE v5.0
Measured: 1 years
Incidence of Laboratory abnormalities
Assessed as per CTCAE v5.0
Measured: 1 years
Duration of response (DoR)
Assessed according to RECIST v1.1
Measured: 1 years
Progression-free Survival (PFS)
Assessed according to RECIST v1.1
Measured: 1 years
Overall Survival (OS)
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start7 Apr 2022
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genome & Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Jeeyun Lee, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419362
- Sponsor's protocol ID
- [GNC] GEN001-201
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2022
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety and the Efficacy of GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05419362
- Acronym / sponsor ID
- [GNC] GEN001-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Genome & CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, multicenter, open-label study to evaluate the antitumor activity, efficacy and safety of GEN-001 in combination with avelumab as a third line (3L) or greater line treatment which is not received the Standard of Care (SOC) for patients with PD-L1 positive advanced GC/Gastroesophageal Junction Adenocarcinoma who are not received cancer immunotherapy regimens as mono or combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GEN-001 with avelumab | Experimental | Drug: GEN-001, Drug: Avelumab42 patients in total with metastatic GC/Gastroesophageal Junction Adenocarcinoma who have progressed after 2 prior systemic treatments and confirmed PD-L1 positive expression will be enrolled in this study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEN-001The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10^11 colony-forming units (CFU) | Drug | GEN-001 with avelumab |
| AvelumabAlso: Bavencio800 mg given by intravenous (IV) infusion once every 2 weeks | Drug | GEN-001 with avelumab |
Primary outcome
To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab
Time frame: 1 years
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5 secondary outcomes
Incidence of Adverse Events
Time frame: 1 years
Incidence of Laboratory abnormalities
Time frame: 1 years
Duration of response (DoR)
Time frame: 1 years
Progression-free Survival (PFS)
Time frame: 1 years
Overall Survival (OS)
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeeyun Lee principal investigator
Samsung Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GEN-001 and Avelumab in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Genome & Company at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.