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

• Sponsor: Genome & Company (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05419362
• Collaborator: Merck KGaA, Darmstadt, Germany (Industry), Pfizer (Industry)
• Enrollment: 50
• Locations: 5
• Arm: 1
• Anticipated Duration (Months): 28.8
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer; Gastroesophageal Junction Adenocarcinoma	Drug: GEN-001; Drug: Avelumab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 7, 2022
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GEN-001 with avelumab Up to 50 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

Outcome Measures

Primary Outcome Measures

1. To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab [1 years]

   Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Secondary Outcome Measures

1. Incidence of Adverse Events [1 years]

   Assessed as per CTCAE v5.0

2. Incidence of Laboratory abnormalities [1 years]

   Assessed as per CTCAE v5.0

3. Duration of response (DoR) [1 years]

   Assessed according to RECIST v1.1

4. Progression-free Survival (PFS) [1 years]

   Assessed according to RECIST v1.1

5. Overall Survival (OS) [1 years]

Other Outcome Measures

1. Microbiota [1 years]

   fecal samples will be collected for analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Gyeonggi-do		Korea, Republic of
2	Seoul National University Bundang Hospital	Gyeonggi-do		Korea, Republic of
3	Asan Medical Center	Seoul		Korea, Republic of
4	Samsung Medical Center	Seoul		Korea, Republic of
5	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Genome & Company
• Merck KGaA, Darmstadt, Germany
• Pfizer

Investigators

• Principal Investigator: Jeeyun Lee, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genome & Company
• ClinicalTrials.gov Identifier: NCT05419362
• Other Study ID Numbers: [GNC] GEN001-201
• First Posted: Jun 15, 2022
• Last Update Posted: Jun 16, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Adenocarcinoma; Stomach Neoplasms; Esophageal Neoplasms; Avelumab

Study Results

No Results Posted as of Jun 16, 2022