NCT04489940终止2 期
A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 45
- 主要终点
- Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC)
研究概览
简要总结
The main purpose of this study was to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Study participants have histologically or cytologically confirmed TNBC
- •Absence of human epidermal growth factor receptor 2 (HER2), estrogen receptor, and progesterone receptor expression must be documented (criteria for defining TNBC are outlined in the protocol)
- •Participants must have received at least one line of systemic therapy for metastatic disease and have progressed on the line of therapy immediately prior to study entry. There is no limit to the number of prior therapies
- •Participants may prescreen for HMGA2 expression while on preceding treatment, however screening should only occur if in the opinion of the Investigator, the participant would likely be eligible for study within 6 months
- •Participants must have measurable disease
- •Availability of either archival tumor tissue or fresh core or excisional biopsy of a tumor lesion (primary or metastatic, excluding bone biopsies) is mandatory to determine HMGA2 expression level prior to enrollment
- •HMGA2 high tumor expression is required and will be determined by a central lab
- •Participants who have Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
- •Participants have a life expectancy greater than or equal to (>=) 12 weeks as judged by the Investigator at study start
- •Participants have adequate hematological, hepatic and renal and coagulation function as defined in the protocol
- •Participants with known Human Immunodeficiency Virus (HIV) infections are in general eligible if the criteria as defined in the protocol are met (Food and Drug Administration [FDA] Guidance on Cancer Clinical Trial Eligibility, March 2019)
- •Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections are in general eligible if the criteria as defined in the protocol are met (FDA Guidance on Cancer Clinical Trial Eligibility, March 2019)
- •Other protocol defined inclusion criteria could apply
排除标准
- •Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study intervention
- •Participants must not have received prior cancer treatment with any other immunotherapy or checkpoint inhibitors, or any other immune-modulating monoclonal antibody
- •Participants that received any organ transplantation, including stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
- •Participants with significant acute or chronic infections
- •Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- •Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Bintrafusp alfa
Experimental
干预措施: Bintrafusp alfa (Drug)
结局指标
主要结局
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC)
时间窗: Time from first study intervention up to 321 days
The ORR was defined as the percentage of participants with a confirmed objective response of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 as assessed by IRC. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.
次要结局
- Overall Survival (OS)(Time from the first dose of study drug until occurrence of death due to any cause, assessed up to 321 days)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, and Adverse Events of Special Interest (AESIs)(Time from first study intervention up to 321 days)
- Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator(From first documented objective response to PD or death due to any cause, assessed up to 321 days)
- Durable Response Rate (DRR) of at Least 6 Months Assessed by an Independent Review Committee (IRC)(Time from first study intervention up to 321 days)
- Progression-Free Survival (PFS) According to RECIST Version 1.1 Assessed by the IRC(Time from first study intervention up to until the first documentation of PD or death, assessed up to 321 days)
- Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator(Time from first study intervention up to 321 days)
- Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator(Time from first study intervention up to 321 days)
- Duration of Response (DOR) According to RECIST Version 1.1(From first documented objective response to PD or death due to any cause, assessed up to 321 days)
- Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa(Pre-dose, End of Infusion from Day 1 to 321)
- Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa(Pre-dose, End of Infusion from Day 1 to 321)
- Number of Participants With Positive Anti-Drug Antibody (ADA) of Bintrafusp Alfa(Pre-dose, End of Infusion from Day 1 to 321)
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator(Time from first study intervention up to the first documentation of PD or death, assessed up to 321 days)
研究者
研究点 (45)
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