Back to resultsTherapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer (Conerstone3)
Primary Purpose
Gastric Cancer
Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
AST-301
rhuGM-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Key Inclusion Criteria: Underwent a curative surgery with standard lymph node dissection (confirmed with no residual tumor, R0 resection) and have completed standard adjuvant treatment Has stages II or III according to the 8th edition of the American Joint Committee on Cancer (AJCC) HER2 low expression and HER2 overexpression diagnosed according to the 2016 College of American Pathologists (CAP)/American Society for Clinical Pathology (ASCP)/American Society of Clinical Oncology (ASCO) guidelines Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Demonstrates adequate organ function. Key Exclusion Criteria: Has a history of hypersensitivity or other contraindications to rhuGM-CSF Has a history of other malignancies ≤5 years prior to first administration of Investigational Product (IP) except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease. Has received systemic immunosuppressants or were treated with systemic immunosuppressants ≤4 weeks prior to the first administration of Investigational Product (IP). Has a history of autoimmune disease or inflammatory disease Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection Is pregnant or breastfeeding or expecting to conceive children
Sites / Locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- China Medical University HospitalRecruiting
- Taichung Veterans General Hospital
- Chi Mei Medical Center
- Taipei Veterans General HospitalRecruiting
- Chang Gung Memorial Hospital Linkou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Total 300 μg of AST-301
Total 600 μg of AST-301
Arm Description
AST-301/rhuGM-CSF (3-week interval, 3 cycles in total)
AST-301/rhuGM-CSF (3-week interval, 6 cycles in total)
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0.
To assess the safety of AST-301 administered in gastric cancer patients.
Immunologic efficacy of AST-301 immunization
AST-301 specific interferon (IFN)-gamma enzyme-linked immune absorbent spot (ELISpot) assay
Secondary Outcome Measures
1year Disease-Free Survival rate (DFS rate)
disease free survival rate at 1 year
Disease-Free Survival rate (DFS rate) at end of study (EOS)
disease free survival at end of study
Compare immunogenicity of AST-301 between Arm 1 and Arm 2
AST-301-specific IFN γ response by ELISpot assay
Change in central memory T-cell populations between Arm 1 and Arm 2
Central memory T-cell (cluster of differentiation 4 (CD4) + and cluster of differentiation 8 (CD8) +) by a flow cytometry analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05771584
Brief Title
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer
Acronym
Conerstone3
Official Title
A Phase 2 Study to Evaluate the Safety and Immunological Efficacy of Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Expressing Gastric Cancer (CORNERSTONE-003)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
June 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aston Sci. Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this early proof-of-concept study to evaluate the safety and immunologic efficacy of AST-301 in gastric cancer patients with HER2 expression (including both HER2 low expression and overexpression) who have completed the standard adjuvant treatment (including those who discontinued the standard adjuvant treatment due to intolerance).
Participants will be randomized 1:1 to either Arm 1 (Q3W, 3 cycles), or Arm 2 (Q3W, 6 cycles) of the study.
Safety Monitoring Committee (SMC) will oversee safety of study at 25% (6 participants), 50% (12 participants), and 75% (18 participants) of participants receive at least 1 dose of AST-301 and survival follow up will be performed to determine disease-free survival (DFS).
Detailed Description
Participants will provide informed consent and will undergo Pre-Screening/Screening procedures before taking part in the study. Participants will be in Arm 1 and Arm 2 will be conducted in parallel. AST-301 will be administrated every 3 weeks for a total of 3 immunizations in Arm 1 and a total of 6 immunizations in Arm 2.
Arm 1: 3 immunizations of AST-301 admixed with immunoadjuvant recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) administered at 3-week intervals. (Total 300 μg of AST-301)
Arm 2: 6 immunizations of AST-301 admixed with immunoadjuvant recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) administered at 3-week intervals. (Total 600 μg of AST-301) Randomization will be stratified according to HER2 expression (HER2 low expression or HER2 overexpression).
For both Arm 1 and Arm 2 of the study there will be a Pre-screen period, followed by study periods: a Screening Period (Day -28 to Day -1), a Treatment Period (3 cycles/Arm 1 and 6 cycles/Arm 2), an end of treatment (EOT) visit and follow-up visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase 2, open label, randomized, early proof-of-concept study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total 300 μg of AST-301
Arm Type
Experimental
Arm Description
AST-301/rhuGM-CSF (3-week interval, 3 cycles in total)
Arm Title
Total 600 μg of AST-301
Arm Type
Experimental
Arm Description
AST-301/rhuGM-CSF (3-week interval, 6 cycles in total)
Intervention Type
Drug
Intervention Name(s)
AST-301
Other Intervention Name(s)
pNGVL3-hICD
Intervention Description
100 μg
Intervention Type
Drug
Intervention Name(s)
rhuGM-CSF
Other Intervention Name(s)
Leukine, Sargramostim
Intervention Description
100 μg
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0.
Description
To assess the safety of AST-301 administered in gastric cancer patients.
Time Frame
up to 20 weeks
Title
Immunologic efficacy of AST-301 immunization
Description
AST-301 specific interferon (IFN)-gamma enzyme-linked immune absorbent spot (ELISpot) assay
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
1year Disease-Free Survival rate (DFS rate)
Description
disease free survival rate at 1 year
Time Frame
12 months
Title
Disease-Free Survival rate (DFS rate) at end of study (EOS)
Description
disease free survival at end of study
Time Frame
Overall study period approximately 31 months
Title
Compare immunogenicity of AST-301 between Arm 1 and Arm 2
Description
AST-301-specific IFN γ response by ELISpot assay
Time Frame
52 weeks
Title
Change in central memory T-cell populations between Arm 1 and Arm 2
Description
Central memory T-cell (cluster of differentiation 4 (CD4) + and cluster of differentiation 8 (CD8) +) by a flow cytometry analysis
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Underwent a curative surgery with standard lymph node dissection (confirmed with no residual tumor, R0 resection) and have completed standard adjuvant treatment
Has stages II or III according to the 8th edition of the American Joint Committee on Cancer (AJCC)
HER2 low expression and HER2 overexpression diagnosed according to the 2016 College of American Pathologists (CAP)/American Society for Clinical Pathology (ASCP)/American Society of Clinical Oncology (ASCO) guidelines
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Demonstrates adequate organ function.
Key Exclusion Criteria:
Has a history of hypersensitivity or other contraindications to rhuGM-CSF
Has a history of other malignancies ≤5 years prior to first administration of Investigational Product (IP) except for adequately treated non-melanoma skin cancer or epithelial carcinoma without evidence of disease.
Has received systemic immunosuppressants or were treated with systemic immunosuppressants ≤4 weeks prior to the first administration of Investigational Product (IP).
Has a history of autoimmune disease or inflammatory disease
Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
Is pregnant or breastfeeding or expecting to conceive children
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minghua Huang, MD
Phone
82-2-2038-2347
Email
mhhwang@astonsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eunkyo Joung, MD, CMO
Email
eunkyo.joung@astonsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minghua Huang, MD
Organizational Affiliation
Aston Sci. Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I-CHEN WU, MD
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LI-YUAN BAI, MD
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SHAO-CIAO LUO, MD
Facility Name
Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YIN-HSUN FENG, MD
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MING-HUANG CHEN, MD
Facility Name
Chang Gung Memorial Hospital Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WEN-CHI CHOU, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Gastric Cancer
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