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

NCT05419362 | Completed Phase 2 DMC

• 1 other identifier: [GNC] GEN001-201
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of Adverse Events

  1 years

• Incidence of Laboratory abnormalities

  1 years

• Duration of response (DoR)

  1 years

• Progression-free Survival (PFS)

  1 years

• Overall Survival (OS)

  1 years

Other Outcomes (1)

• Microbiota

  1 years

Study Arms (1)

GEN-001 with avelumab

EXPERIMENTAL

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; Drug: Avelumab

Interventions

GEN-001 DRUG

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

GEN-001 with avelumab

Avelumab DRUG

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

Also known as: Bavencio

GEN-001 with avelumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: collaborator
• Genome & Company: lead

Study Sites (5)

Ajou University Hospital

Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

avelumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jeeyun Lee

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 15, 2022
• Study Start: April 7, 2022
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)