A Phase 1 Multicenter, Open-Label, Dose-Escalation and Expansion Study of NTB-928, a FRα-Targeting Bispecific T Cell Engager, in Subjects With Relapsed/Refractory Ovarian Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Terminal elimination rate constant (λz)
研究概览
简要总结
The goal of this clinical trial is to determine if NTB-928 can be given safely to adult females with ovarian cancer that has come back (relapsed) or stopped responding to treatment (refractory), how NTB-928 moves through the body, and how the immune system reacts to it. The study will also look for early signs of anti-cancer activity of NTB-928. The main questions the study aims to answer are:
- What side effects do participants experience when receiving NTB-928, including side effects that limit how much of it can be safely given?
- How is NTB-928 processed by the body at different dose levels?
- Does the immune system react to NTB-928 during treatment?
- What dose of NTB-928 can be given safely that shows early signs of activity against ovarian cancer?
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Have a confirmed diagnosis of ovarian cancer, including high-grade serous, high-grade endometrioid, low-grade serous, or clear cell ovarian cancer, or carcinosarcoma of the ovary. Patients with mucinous carcinoma are not eligible.
- •Have relapsed or refractory ovarian cancer and have already received standard treatments known to provide benefit; participants are eligible if they have platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer (with clearly documented ineligibility for further platinum chemotherapy).
- •Are able to understand the study requirements and are willing to provide written informed consent
- •Are willing to use effective birth control during the study and for a period after the last dose of study treatment, if of childbearing potential
排除标准
- •Have another active cancer that could interfere with assessment of this study treatment
- •Have received another investigational drug or certain cancer treatments within a recent period before starting this study
- •Are pregnant or breastfeeding
研究组 & 干预措施
NTB-928 Treatment
干预措施: NTB-928 (Drug)
结局指标
主要结局
Terminal elimination rate constant (λz)
时间窗: Up to approximately 3 years
Volume of distribution (Vz)
时间窗: Up to approximately 3 years
Accumulation ratio (Rac) for Cmax and AUC, and trough concentration (Ctrough)
时间窗: Up to approximately 3 years
Time to Cmax (Tmax)
时间窗: Up to approximately 3 years
Area under the plasma concentration-time curve (AUC) over the dosing interval (AUC0-T)
时间窗: Up to approximately 3 years
AUC from time zero to time t (AUC0-t)
时间窗: Up to approximately 3 years
AUC from time 0 extrapolated to infinity (AUC0-∞)
时间窗: Up to approximately 3 years
Terminal elimination half-life (t½)
时间窗: Up to approximately 3 years
Clearance (CL)
时间窗: Up to approximately 3 years
Number of dose-limiting toxicities (DLTs) within the first cycle of treatment with NTB-928
时间窗: Up to 35 days
Number of participants with adverse events (AEs) and serious adverse events (SAEs), by severity and relatedness to NTB-928
时间窗: Up to approximately 3 years
Maximum plasma concentration (Cmax)
时间窗: Up to approximately 3 years
Number of participants with anti-drug antibodies (ADA) at baseline and after treatment
时间窗: Up to approximately 3 years
次要结局
- Objective response rate (ORR), based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)(Up to approximately 3 years)
- Duration of objective response (DOR), based on RECIST v1.1(Up to approximately 3 years)
- Progression-free survival (PFS), based on RECIST v1.1(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 3 years)