Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Conditions
Brief 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 Adenocarcinoma who are not received cancer immunotherapy regimens as mono or combination therapy.
Interventions
DRUGGEN-001
The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU)
DRUGAvelumab
800 mg given by intravenous (IV) infusion once every 2 weeks
Sponsors
Merck KGaA, Darmstadt, Germany
Genome & Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab | 1 years | Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 1 years | Assessed as per CTCAE v5.0 |
| Incidence of Laboratory abnormalities | 1 years | Assessed as per CTCAE v5.0 |
| Progression-free Survival (PFS) | 1 years | Assessed according to RECIST v1.1 |
| Overall Survival (OS) | 1 years | — |
| Duration of response (DoR) | 1 years | Assessed according to RECIST v1.1 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microbiota | 1 years | fecal samples will be collected for analysis |
Countries
South Korea
Outcome results
None listed