GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

Intervention / Treatment
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* Drug: GEN-001
* Drug: Avelumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GEN-001 with avelumab<br>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. | Drug: GEN-001<br>* The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10^11 colony-forming units (CFU)<br>Drug: Avelumab<br>* 800 mg given by intravenous (IV) infusion once every 2 weeks<br>* Other names: Bavencio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Assessed as per CTCAE v5.0 | 1 years | 
| Incidence of Laboratory abnormalities | Assessed as per CTCAE v5.0 | 1 years | 
| Duration of response (DoR) | Assessed according to RECIST v1.1 | 1 years | 
| Progression-free Survival (PFS) | Assessed according to RECIST v1.1 | 1 years | 
| Overall Survival (OS) |  | 1 years |