A Phase II Study of GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genome & Company
• Collaborators: Merck KGaA, Darmstadt, Germany; Pfizer
• Treatments: Avelumab

Criteria

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