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

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ClinicalTrials.gov Identifier: NCT05163223
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Aston Sci. Inc.

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).


Condition or disease Intervention/treatment Phase
Breast Cancer Biological: AST-301(pNGVL3-hICD) Drug: rhuGM-CSF Drug: Placebo Drug: Pembrolizumab Drug: Capecitabine Phase 2

Detailed Description:
Not provided

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 28, 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AST-301(pNGVL3-hICD)+Chemotherapy
  • 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)
Biological: AST-301(pNGVL3-hICD)
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
Other Name: AST-301

Drug: rhuGM-CSF
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection
Other Names:
  • Leukine
  • Sargramostim

Drug: Pembrolizumab
Q3W; IV infusion
Other Name: Keytruda

Drug: Capecitabine
On days 1-14 (Q3W), BID ; Oral administration,
Other Name: Xeloda

Active Comparator: Placebo + Chemotherapy
  • 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)
Drug: rhuGM-CSF
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection
Other Names:
  • Leukine
  • Sargramostim

Drug: Placebo
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
Other Name: Normal Saline

Drug: Pembrolizumab
Q3W; IV infusion
Other Name: Keytruda

Drug: Capecitabine
On days 1-14 (Q3W), BID ; Oral administration,
Other Name: Xeloda




Primary Outcome Measures :
  1. 2-year invasive disease free survival rate (iDFS) [ 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. ]
    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 :
  1. AST-301 specific T cell immune responses [ Time Frame: Up to approximately 82 weeks ]
    Immune response will be assessed by IFN-gamma enzyme-linked immune absorbent spot (ELISpot) assay

  2. Change in central memory T cell populations [ Time Frame: Up to approximately 82 weeks ]
    Assessment by FACS

  3. Distant Recurrence-Free Survival rate, dRFS rate [ Time Frame: Overall study period approximately up to 4 years ]
    dRFS rate at the end of study

  4. Number of participants with treatment-related adverse events as assessed by CTCAE [ Time Frame: Overall study period approximately up to 4years ]
    To assess safety of AST-301 administered in breast cancer patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05163223


Contacts
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Contact: Eunkyo Joung, CMO 02-2038-2347 eunkyo.joung@astonsci.com
Contact: Aston Sci. Inc, astonsci@astonsci.com

Locations
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United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Mary Nora Disis, PhD         
Australia, South Australia
Cancer Research SA Pty Ltd Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Meena Okera, Dr         
Principal Investigator: Meena Okera, Dr         
Australia, Victoria
Ballarat Health Services (BHS) Recruiting
Ballarat, Victoria, Australia, 3350
Contact: Lee Na Teo, Dr         
Principal Investigator: Lee Na Teo, Dr         
Sponsors and Collaborators
Aston Sci. Inc.
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Responsible Party: Aston Sci. Inc.
ClinicalTrials.gov Identifier: NCT05163223    
Other Study ID Numbers: PN-301-21
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Aston Sci. Inc.:
HER 2 low (1+ or 2+ and non-amplified by FISH)
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pembrolizumab
Capecitabine
Sargramostim
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs