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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05163223
Ethics application status
Date submitted
2/04/2021
Date registered
20/12/2021

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
Treatment: Other - 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)


Treatment: Other: 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
Treatment: Other
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
Stopped early
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
Actual
31/05/2024
Sample size
Target
Accrual to date
Final
10
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
Trial website
Trial related presentations / publications
Public notes

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
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05163223