Phase 1b, Multicentre, Multiple Ascending Dose, Safety, Pharmacokinetic, and Pharmacodynamic Study of Tilvestamab (BGB149) in Relapsed, Platinum-resistant, High-grade Serous Ovarian Cancer (HGSOC) Patients
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 9
- 主要终点
- Number of Participants with Concomitant Medication Use
研究概览
简要总结
The primary purpose is to assess the safety and tolerability of tilvestamab following IV administration of multiple doses to participants with HGSOC who have been treated with at least 1 complete course of platinum-based chemotherapy and whose disease has relapsed with platinum resistance ([PRR]-HGSOC) and to determine the plasma pharmacokinetics (PK) exposure by comprehensive profiling (at single dose and steady-state) of multiple ascending doses of tilvestamab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Females of non-childbearing potential at the time of provision of informed consent
- •Ability to understand and provide written confirmation of informed consent after reading study information, discussion with the investigator, and adequate time to decide on participation
- •Consents to storage of study-related samples and data for exploratory use
- •Histologically confirmed HGSOC
- •Platinum-resistant relapsed disease; defined as progressive disease based on imaging within <= 6 months from completion of most recent regimen
排除标准
- •Primary platinum-refractory disease (ie, progression during the first platinum regimen or within 4 weeks of completion of the first platinum regimen) with rapid progression and life-threatening disease manifestation
- •Life expectancy < 6 months
- •Concurrent anticancer therapy
- •Participants who are breastfeeding
- •Known uncontrolled central nervous system metastases. Participants without known brain metastases do not require radiological imaging prior to enrolment
结局指标
主要结局
Number of Participants with Concomitant Medication Use
时间窗: Up to 2.5 years
Number of participants with concomitant medication use will be reported.
Number of Participants with Adverse events (AEs) and Serious AEs (SAEs)
时间窗: Up to 2.5 years
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening, worsens during the study, regardless of the suspected cause of the event. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants with Laboratory Abnormalities
时间窗: Up to 2.5 years
Number of participants with laboratory (haematology, coagulation, clinical chemistry, serum inflammatory cytokine profile, and urinalysis) abnormalities will be reported.
Number of Participants with Physical Examinations Abnormalities
时间窗: Up to 2.5 years
Number of participants with physical examinations abnormalities will be reported.
Number of Participants with Vital Sign Abnormalities
时间窗: Up to 2.5 years
Number of participants with vital sign (supine blood pressure \[BP\], heart rate, oral temperature, and respiratory rate) abnormalities will be reported.
Number of Participants with Electrocardiogram (ECG) Abnormalities
时间窗: Up to 2.5 years
Number of participants with resting triplicate 12-lead ECG abnormalities will be reported.
Maximum Concentration (Cmax)
时间窗: Up to 140 days
Cmax will be determined directly from the concentration-time profile.
Time to Cmax (Tmax)
时间窗: Up to 140 days
Time to Cmax will be determined directly from the concentration-time profile.
Area Under the Concentration-time Curve (AUC) From Predose (Time 0) to the end of the Dosing Period (AUC0-tau)
时间窗: Up to 140 days
AUC0-tau will be calculated using the linear-log trapezoidal rule.
AUC From Predose (Time 0) to the Time of the Last Quantifiable Concentration (AUClast)
时间窗: Up to 140 days
AUClast will be calculated using the linear-log trapezoidal rule.
AUC From Predose (Time 0) to 168 Hours Postdose (AUC0-168 )
时间窗: Predose up to 168 hours postdose
AUC0-168 is AUC from predose (time 0) to 168 hours postdose.
Terminal Elimination Rate Constant (Lambda[z])
时间窗: Up to 140 days
Lambda\[z\] will be determined by selection of at least 3 data points on the terminal phase of the concentration-time curve.
Terminal Elimination Half-life
时间窗: Up to 140 days
Terminal elimination half-life calculated as: ln2/Lambda\[z\]
Total body clearance (CL)
时间窗: Up to 140 days
CL is defined as total body clearance.
次要结局
- Number of Participants with Neutralizing Antibodies (NAbs)(Up to 2.5 years)
- Number of Participants with Anti-drug Antibodies (ADAs)(Up to 2.5 years)