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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 5
- Primary Endpoint
- To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
GEN-001 with avelumab
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.
Intervention: GEN-001 (Drug)
GEN-001 with avelumab
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.
Intervention: Avelumab (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Progression-free Survival (PFS)(1 years)
- Incidence of Adverse Events(1 years)
- Incidence of Laboratory abnormalities(1 years)
- Duration of response (DoR)(1 years)
- Overall Survival (OS)(1 years)