Clinical trial NCT05163223: Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: HER 2 low (1+ or 2+ and non-amplified by FISH)
Lead sponsor: Aston Sci. Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Not provided

Eligibility criteria: 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

Primary outcomes:
measure: 2-year invasive disease free survival rate (iDFS)
timeFrame: 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 outcomes:
measure: AST-301 specific T cell immune responses
timeFrame: Up to approximately 82 weeks
measure: Change in central memory T cell populations
timeFrame: Up to approximately 82 weeks
measure: Distant Recurrence-Free Survival rate, dRFS rate
timeFrame: Overall study period approximately up to 4 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE
timeFrame: Overall study period approximately up to 4years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Illinois Cancer Center
state: Illinois
city: Omaha
country: United States
facility: Nebraska Cancer Specialist
state: Nebraska
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute
state: Oregon
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei city
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: