Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
NCT ID: NCT05163223
Last Updated: 2024-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2022-02-28
2024-05-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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)
AST-301(pNGVL3-hICD)
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
rhuGM-CSF
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection
Pembrolizumab
Q3W; IV infusion
Capecitabine
On days 1-14 (Q3W), BID ; Oral administration,
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)
rhuGM-CSF
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection
Placebo
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
Pembrolizumab
Q3W; IV infusion
Capecitabine
On days 1-14 (Q3W), BID ; Oral administration,
Interventions
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AST-301(pNGVL3-hICD)
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
rhuGM-CSF
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection
Placebo
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
Pembrolizumab
Q3W; IV infusion
Capecitabine
On days 1-14 (Q3W), BID ; Oral administration,
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Aston Sci. Inc.
INDUSTRY
Responsible Party
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Locations
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Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Scripps Health
La Jolla, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Nebraska Cancer Specialist
Omaha, Nebraska, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
Providence Cancer Institute
Portland, Oregon, United States
University of Washington
Seattle, Washington, United States
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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PN-301-21
Identifier Type: -
Identifier Source: org_study_id
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