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

NCT ID: NCT05419362

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-07
• Study Completion Date: 2024-08-26

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.

Conditions

Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

GEN-001

Intervention Type: DRUG

The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU)

Avelumab

Intervention Type: DRUG

800 mg given by intravenous (IV) infusion once every 2 weeks

Interventions

GEN-001

The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10\^11 colony-forming units (CFU)

Intervention Type: DRUG

Avelumab

800 mg given by intravenous (IV) infusion once every 2 weeks

Intervention Type: DRUG

Other Intervention Names

Bavencio

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

Genome & Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeeyun Lee

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Ajou University Hospital

Gyeonggi-do, , South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

[GNC] GEN001-201

Identifier Type: -

Identifier Source: org_study_id