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Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer (Cornerstone001)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AST-301(pNGVL3-hICD)
rhuGM-CSF
Placebo
Pembrolizumab
Capecitabine
Sponsored by
Aston Sci. Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring HER 2 low (1+ or 2+ and non-amplified by FISH)

Eligibility Criteria

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

Key Inclusion Criteria:

  • Has a residual invasive cancer in the breast(non-pCR) after neoadjuvant treatment
  • Has stage I, II, or III disease prior to surgery per American Joint Committee on Cancer (AJCC)
  • HER 2 1+ by IHC or HER2 2+by IHC without gene amplification by ISH, as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
  • Hormone receptor (ER and PR) negative by ASCO/CAP guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Demonstrates adequate organ function.

Key Exclusion Criteria:

  • Has a history of hypersensitivity or other contraindications to rhGM-CSF
  • Has a history of invasive malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or carcinoma in situ.
  • Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs
  • 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

  • Ironwood Cancer and Research CentersRecruiting
  • Scripps Health
  • Moffitt Cancer Center
  • University of Illinois Cancer CenterRecruiting
  • Nebraska Cancer SpecialistRecruiting
  • Gabrail Cancer Center ResearchRecruiting
  • The Ohio State University Comprehensive Cancer Center
  • Toledo Clinic Cancer CenterRecruiting
  • Providence Cancer InstituteRecruiting
  • University of WashingtonRecruiting
  • Changhua Christian HospitalRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • Chi Mei Medical CenterRecruiting
  • Koo Foundation Sun Yat-Sen Cancer CenterRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AST-301(pNGVL3-hICD)+Chemotherapy

Placebo + Chemotherapy

Arm Description

AST-301/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy* A booster (AST-301/rhuGM-CSF) at 24 weeks post the third vaccination Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks)

Placebo/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy* A booster (Placebo/rhuGM CSF) at 24 weeks post the third vaccination Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks)

Outcomes

Primary Outcome Measures

2-year invasive disease free survival rate (iDFS)
iDFS event is defined as Ipsilateral breast tumor recurrence Local/regional invasive recurrence Distant recurrence Invasive contralateral breast cancer Death (from breast cancer/non-breast cancer cause/unknown cause) Secondary primary invasive cancer (non-breast)

Secondary Outcome Measures

AST-301 specific T cell immune responses
Immune response will be assessed by IFN-gamma enzyme-linked immune absorbent spot (ELISpot) assay
Change in central memory T cell populations
Assessment by FACS
Distant Recurrence-Free Survival rate, dRFS rate
dRFS rate at the end of study
Number of participants with treatment-related adverse events as assessed by CTCAE
To assess safety of AST-301 administered in breast cancer patients.

Full Information

First Posted
April 2, 2021
Last Updated
July 18, 2023
Sponsor
Aston Sci. Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05163223
Brief Title
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
Acronym
Cornerstone001
Official Title
A Phase 2 Study to Evaluate the Efficacy and Safety of an Adjuvant Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With HER2 Low Breast Cancer (Cornerstone-001)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (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 study is to evaluate the efficacy and safety of an adjuvant treatment of therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in patients with HER2-low expression (IHC 1+ or 2+ and ISH-) and hormone receptor-negative(ER-, PR-) breast cancer with residual disease after neoadjuvant treatment. Patients will be randomized 1:1 to either the Experimental arm (combination of AST-301/rhuGM CSF and standard adjuvant therapy) or the Control arm (combination of placebo/rhuGM CSF and standard adjuvant therapy). Standard adjuvant chemotherapy will be pembrolizumab or capecitabine. Adjuvant therapy will be administered in compliance with the NCCN guideline for breast cancer (Version 8, 2021), and IP (AST-301) will be administered 3 times every 3 weeks in the adjuvant treatment period, with a booster administered at 24 weeks (±7 days) post the third dose of IP administration. Survival follow up will be performed to determine invasive Disease Free survival(iDFS).
Detailed Description
Not provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
HER 2 low (1+ or 2+ and non-amplified by FISH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AST-301(pNGVL3-hICD)+Chemotherapy
Arm Type
Experimental
Arm Description
AST-301/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy* A booster (AST-301/rhuGM-CSF) at 24 weeks post the third vaccination Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks)
Arm Title
Placebo + Chemotherapy
Arm Type
Active Comparator
Arm Description
Placebo/rhuGM-CSF (q 3 weeks, 3 cycles) + Standard adjuvant therapy* A booster (Placebo/rhuGM CSF) at 24 weeks post the third vaccination Standard adjuvant therapy will be pembrolizumab or capecitabine (q 3 weeks)
Intervention Type
Biological
Intervention Name(s)
AST-301(pNGVL3-hICD)
Other Intervention Name(s)
AST-301
Intervention Description
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
Intervention Type
Drug
Intervention Name(s)
rhuGM-CSF
Other Intervention Name(s)
Leukine, Sargramostim
Intervention Description
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
Q3W; IV infusion
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
On days 1-14 (Q3W), BID ; Oral administration,
Primary Outcome Measure Information:
Title
2-year invasive disease free survival rate (iDFS)
Description
iDFS event is defined as Ipsilateral breast tumor recurrence Local/regional invasive recurrence Distant recurrence Invasive contralateral breast cancer Death (from breast cancer/non-breast cancer cause/unknown cause) Secondary primary invasive cancer (non-breast)
Time Frame
Overall study period approximately up to 4years (End of study in this study is defined as 2years frm the date of last Patient In.
Secondary Outcome Measure Information:
Title
AST-301 specific T cell immune responses
Description
Immune response will be assessed by IFN-gamma enzyme-linked immune absorbent spot (ELISpot) assay
Time Frame
Up to approximately 82 weeks
Title
Change in central memory T cell populations
Description
Assessment by FACS
Time Frame
Up to approximately 82 weeks
Title
Distant Recurrence-Free Survival rate, dRFS rate
Description
dRFS rate at the end of study
Time Frame
Overall study period approximately up to 4 years
Title
Number of participants with treatment-related adverse events as assessed by CTCAE
Description
To assess safety of AST-301 administered in breast cancer patients.
Time Frame
Overall study period approximately up to 4years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Has a residual invasive cancer in the breast(non-pCR) after neoadjuvant treatment Has stage I, II, or III disease prior to surgery per American Joint Committee on Cancer (AJCC) HER 2 1+ by IHC or HER2 2+by IHC without gene amplification by ISH, as defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Hormone receptor (ER and PR) negative by ASCO/CAP guidelines Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Demonstrates adequate organ function. Key Exclusion Criteria: Has a history of hypersensitivity or other contraindications to rhGM-CSF Has a history of invasive malignancy ≤5 years prior to first administration of investigational drug except for adequately treated non-melanoma skin cancer or carcinoma in situ. Is on immune suppression therapy or has a history of immune suppression therapy ≤4 weeks prior to the first administration of investigational drugs 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
Eunkyo Joung, CMO
Phone
02-2038-2347
Email
eunkyo.joung@astonsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aston Sci. Inc,
Email
astonsci@astonsci.com
Facility Information:
Facility Name
Ironwood Cancer and Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KALMADI SUJITH, MD
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOHAMMED JALOUDI, MD
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aixa Soyano, MD
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VIJAYAKRISHNA GADI, MD
Facility Name
Nebraska Cancer Specialist
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SARAH CREAMER, MD
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NASHAT Y GABRAIL, MD
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Johnson, MD
Facility Name
Toledo Clinic Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
REX MOWAT, MD
Facility Name
Providence Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SASHA STANTON, MD
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Nora Disis, MD
Facility Name
Changhua Christian Hospital
City
Changhua City
ZIP/Postal Code
500
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SHOU-TUNG CHEN, MD
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MING-FENG HOU, MD
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LIANG-CHIH LIU, MD
Facility Name
Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NAI-WEN KANG, MD
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei city
ZIP/Postal Code
11259
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHI-FENG CHUNG, MD
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHIUN-SHENG HUANG, MD
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LING-MING TSENG, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer

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