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

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

Status
Active
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GEN-001
Avelumab
Sponsored by
Genome & Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou University Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Yonsei University Health System, Severance Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GEN-001 with avelumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2022
Last Updated
October 15, 2023
Sponsor
Genome & Company
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT05419362
Brief Title
GEN-001 in Combination With Avelumab for Patients With PD-L1 Positive Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genome & Company
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GEN-001 with avelumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GEN-001
Intervention Description
The capsules taken by mouth once a daily. Each capsule will contain ≥ 3x10^11 colony-forming units (CFU)
Intervention Type
Drug
Intervention Name(s)
Avelumab
Other Intervention Name(s)
Bavencio
Intervention Description
800 mg given by intravenous (IV) infusion once every 2 weeks
Primary Outcome Measure Information:
Title
To assess the anti-tumor activity of GEN-001, when administered as combined with avelumab
Description
Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events
Description
Assessed as per CTCAE v5.0
Time Frame
1 years
Title
Incidence of Laboratory abnormalities
Description
Assessed as per CTCAE v5.0
Time Frame
1 years
Title
Duration of response (DoR)
Description
Assessed according to RECIST v1.1
Time Frame
1 years
Title
Progression-free Survival (PFS)
Description
Assessed according to RECIST v1.1
Time Frame
1 years
Title
Overall Survival (OS)
Time Frame
1 years
Other Pre-specified Outcome Measures:
Title
Microbiota
Description
fecal samples will be collected for analysis
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeeyun Lee
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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