NCT05163223

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Aston Sci. Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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
DRUG	Placebo	Q3W, 3 cycles, Plus a booster at 24 weeks post the third vaccination, Intradermal injection
DRUG	Pembrolizumab	Q3W; IV infusion
DRUG	Capecitabine	On days 1-14 (Q3W), BID ; Oral administration,

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2021-12-20
• Last updated: 2024-06-17

Locations

17 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study