Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05163223




Registration number
NCT05163223
Ethics application status
Date submitted
2/04/2021
Date registered
20/12/2021
Date last updated
20/07/2023

Titles & IDs
Public title
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
Scientific 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)
Secondary ID [1] 0 0
PN-301-21
Universal Trial Number (UTN)
Trial acronym
Cornerstone001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - AST-301(pNGVL3-hICD)
Treatment: Drugs - rhuGM-CSF
Treatment: Drugs - Placebo
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Capecitabine

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)

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)


Other interventions: AST-301(pNGVL3-hICD)
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection

Treatment: Drugs: rhuGM-CSF
Q3W, 3 cycles, Plus a booster at 24weeks post the third vaccination, Intradermal injection

Treatment: Drugs: Placebo
Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection

Treatment: Drugs: Pembrolizumab
Q3W; IV infusion

Treatment: Drugs: Capecitabine
On days 1-14 (Q3W), BID ; Oral administration,
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
2-year invasive disease free survival rate (iDFS)
Timepoint [1] 0 0
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 [1] 0 0
AST-301 specific T cell immune responses
Timepoint [1] 0 0
Up to approximately 82 weeks
Secondary outcome [2] 0 0
Change in central memory T cell populations
Timepoint [2] 0 0
Up to approximately 82 weeks
Secondary outcome [3] 0 0
Distant Recurrence-Free Survival rate, dRFS rate
Timepoint [3] 0 0
Overall study period approximately up to 4 years
Secondary outcome [4] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE
Timepoint [4] 0 0
Overall study period approximately up to 4years

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Taiwan
State/province [9] 0 0
Changhua City
Country [10] 0 0
Taiwan
State/province [10] 0 0
Kaohsiung
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taichung City
Country [12] 0 0
Taiwan
State/province [12] 0 0
Tainan
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taipei city
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taipei City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Aston Sci. Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05163223
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Eunkyo Joung, CMO
Address 0 0
Country 0 0
Phone 0 0
02-2038-2347
Fax 0 0
Email 0 0
eunkyo.joung@astonsci.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05163223