Phase 2, Multi-Center, Randomized, Open-Label Trial of BDC-1001 as a Single Agent and in Combination With Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab Deruxtecan
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Objective Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigator
研究概览
简要总结
This is an open-label, Phase 2 study to evaluate preliminary anti-tumor activity, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of BDC-1001 administered as a single agent and in combination with pertuzumab in subjects with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) previously treated with trastuzumab deruxtecan (Enhertu®).
详细描述
Eligible subjects will be randomly assigned in a 1:1 ratio to receive BDC-1001 as a single agent or BDC-1001 in combination with pertuzumab. Within each treatment arm, a Simon 2-stage design will be applied. Subjects will receive study treatment (i.e., BDC-1001 or BDC-1001 in combination with pertuzumab) for up to 24 months after Cycle 1 Day 1 (C1D1), until disease progression, unacceptable toxicity, or withdrawal for any reason.
Bolt amended the protocol to transition any subjects still receiving BDC-1001 to continue receiving BDC-1001 in the Maintenance Phase. Subjects remaining on BDC-1001 will continue to receive BDC-1001 until a criterion for discontinuation has been met.
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
- None
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
- •Histologically confirmed adenocarcinoma of the breast that is HER2+ (IHC 3+ or gene amplification by ISH or NGS).
- •Have received 2 or more prior lines of anti-HER2-directed therapies, at least 1 in the metastatic setting and including trastuzumab deruxtecan.
- •Measurable disease as determined by RECIST v.1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Have life expectancy of greater than 12 weeks per the Investigator.
- •All subjects must agree to have a biopsy prior to enrollment. If, in the judgment of the Investigator, a biopsy is not safely accessible or clinically feasible an archival tumor tissue sample must be submitted in lieu of a freshly collected specimen.
排除标准
- •History of severe hypersensitivity to any ingredient of BDC-1001 or pertuzumab.
- •Previous treatment with a small molecule TLR7/8 agonist or TLR7/8 agonist that has been conjugated to tumor-targeting antibody such as ISACs within 12 months before starting study treatment.
- •Impaired cardiac function or history of clinically significant cardiac disease.
- •Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
- •Central nervous system metastases with the exception of disease that is asymptomatic, clinically stable, and has not required steroids for at least 28 days before starting study treatment.
研究组 & 干预措施
BDC-1001 Single Agent
BDC-1001 administered intravenously (IV) every 2 weeks
干预措施: BDC-1001 (Drug)
BDC-1001 in Combination With Pertuzumab
BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
干预措施: BDC-1001 (Drug)
BDC-1001 in Combination With Pertuzumab
BDC-1001 administered intravenously (IV) every 2 weeks, in combination with pertuzumab administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose every 3 weeks.
干预措施: Pertuzumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Per RECIST v1.1 as Assessed by Investigator
时间窗: Up to approximately 1 year
Objective Response Rate (ORR) was defined as the proportion of participants with best overall response of confirmed Complete Response (CR) or Partial Response (PR) as determined by the treating Investigator using RECIST v1.1 criteria.
次要结局
- Duration of Response (DOR) Per RECIST v1.1 as Assessed by Investigator(Up to approximately 1 year)
- Overall Survival (OS)(Up to approximately 1 year)
- Number of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)(Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year)
- Disease Control Rate (DCR) Per RECIST v1.1 as Assessed by Investigator(Up to approximately 1 year)
- Number of Participants With Any Treatment Emergent Serious Adverse Event (SAE) Related to Study Treatment(Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year.)
- Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Investigator(Up to approximately 1 year)
- Number of Participants Who Had Any Treatment Emergent Adverse Event (TEAE) Related to Study Treatment(Continuously from first dose of study treatment through end of treatment and Safety Follow-Up. Up to approximately 1 year.)