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)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 17
- 主要终点
- 2-year invasive disease free survival rate (iDFS)
研究概览
简要总结
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).
详细描述
Not provided
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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)
干预措施: AST-301(pNGVL3-hICD) (Biological)
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)
干预措施: rhuGM-CSF (Drug)
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)
干预措施: Pembrolizumab (Drug)
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)
干预措施: Capecitabine (Drug)
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)
干预措施: rhuGM-CSF (Drug)
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)
干预措施: Placebo (Drug)
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)
干预措施: Pembrolizumab (Drug)
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)
干预措施: Capecitabine (Drug)
结局指标
主要结局
2-year invasive disease free survival rate (iDFS)
时间窗: Overall study period approximately up to 4years (End of study in this study is defined as 2years frm the date of last Patient In.
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)
次要结局
- Change in central memory T cell populations(Up to approximately 82 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE(Overall study period approximately up to 4years)
- Distant Recurrence-Free Survival rate, dRFS rate(Overall study period approximately up to 4 years)
- AST-301 specific T cell immune responses(Up to approximately 82 weeks)