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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
Date last updated
17/06/2024

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Comparator / control treatment
Control group

Outcomes
Secondary outcome [1] 0 0
Secondary outcome
Timepoint [1] 0 0
120-140 weeks

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)

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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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