An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905677 Administered Intravenously in Patients With Advanced Solid Tumours
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 5
- 主要终点
- Number of Participants With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This study is open to adults with different types of advanced cancer (solid tumours). This study is open to people in whom previous treatments were not successful. The purpose of this study is to find out the highest dose of BI 905677 the participants can tolerate. BI 905677 is a type of an antibody that is being developed to treat cancer.
One dose of BI 905677 is given to the participants every 2 or 3 weeks as infusion into a vein. In this study, BI 905677 is given to humans for the first time. The participants visit the study site at least once a week so that the doctors can check their general health. The participants are in the study for as long as they benefit from and can tolerate treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 905677 0.05 mg/kg
0.05 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.
干预措施: BI 905677 (Drug)
BI 905677 0.1 mg/kg
0.1 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.
干预措施: BI 905677 (Drug)
BI 905677 0.2 mg/kg
0.2 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.
干预措施: BI 905677 (Drug)
BI 905677 0.4 mg/kg
0.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.
干预措施: BI 905677 (Drug)
BI 905677 0.8 mg/kg
0.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.
干预措施: BI 905677 (Drug)
BI 905677 1.6 mg/kg
1.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.
干预措施: BI 905677 (Drug)
BI 905677 2.4 mg/kg
2.4 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.
干预措施: BI 905677 (Drug)
BI 905677 2.8 mg/kg
2.8 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.
干预措施: BI 905677 (Drug)
BI 905677 3.6 mg/kg
3.6 milligrams (mg) per kilogram (kg) solution for infusion BI 905677 were administered intravenously on Day 1 of each 3-week treatment cycle. Patients may continue on treatment for unlimited cycles, until disease progression or other criteria for stopping treatment are met.
干预措施: BI 905677 (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities (DLTs)
时间窗: In the first treatment cycle, up to 3 weeks
The number of participants with Dose Limiting Toxicities (DLTs) is reported. Any of the following adverse events (AEs) will be classified as DLTs following review by the Safety Monitoring Committee and the Medical Monitor, unless unequivocally due to underlying malignancy or an extraneous cause, including any AE which prevents a patient starting Cycle 2 within 14 days of completion of Cycle 1; Bone mineral density change of \>5% from baseline, confirmed at least 2 months after initial observation; β-CTX increase of more than two-fold from baseline; Grade 3 osteoporosis, and so on.
Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period
时间窗: From first dose until last dose + 42 days (6 weeks) of residual effect period, up to 36 weeks.
The Number of patients experiencing adverse events (AEs) during the entire treatment period is reported.
次要结局
- Maximum Measured Concentration of BI 905677 in Serum After First Infusion (Cmax)(5 minutes (min) before and at 1, 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.)
- Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (AUC0-tz)(5 minutes (min) before and at 1 1.5, 4, 8, 24, 72, 168 and 336 hour(s) after first dosing in Cycle 1.)