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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: GEN-001; Drug: Avelumab

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Group; Phone Number: +82316280150; Email: GNC_Clinical_201@genomecom.co.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Ajou University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Yonsei University Health System, Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: GEN-001; The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10^11 colony-forming units (CFU); Drug: Avelumab; 800 mg given by intravenous (IV) infusion once every 2 weeks; Other Names: Bavencio

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Assessed as per CTCAE v5.0	1 years
Incidence of Laboratory abnormalities	Assessed as per CTCAE v5.0	1 years
Duration of response (DoR)	Assessed according to RECIST v1.1	1 years
Progression-free Survival (PFS)	Assessed according to RECIST v1.1	1 years
Overall Survival (OS)		1 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota	fecal samples will be collected for analysis	1 years

Collaborators and Investigators

• Sponsor: Genome & Company
• Collaborators: Merck KGaA, Darmstadt, Germany
• Investigators: Principal Investigator: Jeeyun Lee, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Stomach Neoplasms; Adenocarcinoma; Esophageal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Avelumab
• Other Study ID Numbers: [GNC] GEN001-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No