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

Breast Cancer Clinical Trial

— Cornerstone001  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05163223
• Other study ID #: PN-301-21
• Status: Terminated
• Phase: Phase 2
• Start date: February 28, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2024
• Source: Aston Sci. Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Not provided

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Drug:
• 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,

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Changhua City
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung City
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei city
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Taipei Veterans General Hospital	Taipei City
United States	Gabrail Cancer Center Research	Canton	Ohio
United States	Ironwood Cancer and Research Centers	Chandler	Arizona
United States	University of Illinois Cancer Center	Chicago	Illinois
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Scripps Health	La Jolla	California
United States	Nebraska Cancer Specialist	Omaha	Nebraska
United States	Providence Cancer Institute	Portland	Oregon
United States	University of Washington	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida
United States	Toledo Clinic Cancer Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Aston Sci. Inc.

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year invasive disease free survival rate (iDFS)	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)	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	AST-301 specific T cell immune responses	Immune response will be assessed by IFN-gamma enzyme-linked immune absorbent spot (ELISpot) assay	Up to approximately 82 weeks
Secondary	Change in central memory T cell populations	Assessment by FACS	Up to approximately 82 weeks
Secondary	Distant Recurrence-Free Survival rate, dRFS rate	dRFS rate at the end of study	Overall study period approximately up to 4 years
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE	To assess safety of AST-301 administered in breast cancer patients.	Overall study period approximately up to 4years