2024-511646-40-00招募中2 期
A Phase IB/II, 2-Stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer (BEGONIA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 61
- 试验地点
- 6
- 主要终点
- Part 1: AEs, exposure, physical examinations, laboratory findings, and vital signs
研究概览
简要总结
Part 1: To assess the safety and tolerability profile of durvalumab + novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel. Part 2: To assess the efficacy of durvalumab + novel oncology therapies with or without paclitaxel in terms of ORR.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Part 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age at the time of screening
- •Patient must have locally confirmed advanced/unresectable or metastatic TNBC
- •No prior treatment for metastatic (Stage IV) TNBC
- •Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured
- •WHO/ECOG status at 0 or 1 at enrollment
- •Patients enrolled to Arm 6 (durvalumab and DS-8201a): Must provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH–, IHC 1+/ISH–, or IHC 1+/ISH untested
- •Patients enrolled in Arm 8 (durvalumab + Dato-DXd): Must have PD-L1 positive tumor as determined by an IHC based assay
排除标准
- •History of allogeneic organ transplantation
- •Patients enrolled in Arm 2 only: Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment
- •Patients enrolled in Arm 5 only: History of venous thromboembolism in the past 3 months
- •Patients enrolled in Arm 7 and Arm 8 only: Clinically significant corneal disease in the opinion of the Investigator.
- •Patients enrolled in Arm 6, 7 and 8 only: History of or active interstitial lung disease/pneumonitis
- •Patients enrolled in Arm 6, 7 and 8 only: Use of chloroquine or hydroxychloroquine in <14 days prior to Day 1 of DS-8201a (Arm 6) or Dato-DXd (Arm 7 and Arm 8) treatment
- •Patients enrolled in Arm 6 only: Previously been diagnosed as HER2+ or received HER2-targeted therapy
- •Active or prior documented autoimmune or inflammatory disorders
- •Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies)
- •Untreated CNS metastases
- •Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- •Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
- •Female patients who are pregnant, breastfeeding
- •Cardiac Ejection Fraction less than 50%
- •Patients enrolled in Arm 2 only: Potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John’s Wort)
结局指标
主要结局
Part 1: AEs, exposure, physical examinations, laboratory findings, and vital signs
Part 1: AEs, exposure, physical examinations, laboratory findings, and vital signs
Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response).
Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response).
次要结局
- Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response)
- Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: PFS (progression-free survival): Time from date of first dose until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression
- Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: DoR (duration of response): Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression
- Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: OS (overall survival): Time from date of first dose until the date of death by any cause
- Part 1: Serum concentration of durvalumab and serum or plasma concentration of novel oncology therapies
- Part 1: Presence of ADAs for durvalumab and applicable novel oncology therapies
- Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: PFS (progression-free survival): Time from date of first dose until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression)
- Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: DoR (duration of response): Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression
- Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: PFS6: PFS at 6 months following date of first dose
- Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: OS (overall survival): Time from date of first dose until the date of death by any cause
- Part 2: AEs, exposure, physical examinations, laboratory findings, and vital signs
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (6)
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