Phase I, First in Human Trial Evaluating BI 1387446 Alone and in Combination With Ezabenlimab (BI 754091) in Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- Maximum Tolerated Dose (MTD) Based on Number of Dose-limiting Toxicities (DLTs)
研究概览
简要总结
This is a study in adults with advanced cancer (solid tumours) in whom previous treatment was not successful. The study tests 2 medicines called BI 1387446 and BI 754091. Both medicines may help the immune system fight cancer. In this study, BI 1387446 is given to humans for the first time.
The purpose of this study is to find out the highest dose of BI 1387446 alone and in combination with BI 754091 the participants can tolerate. BI 1387446 is injected directly into the tumour.
Participants get BI 1387446 injections every week at the beginning and then every 3 weeks.
Some participants get BI 754091 in addition to BI 1387446. BI 754091 is given as an infusion into a vein every 3 weeks.
As long as they benefit from treatment and can tolerate it, participants can stay in the study for up to 2 years and 8 months. During this time, they visit the study site regularly. At these visit, doctors record any unwanted effects. The doctors also regularly check participants' health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
Arm A: BI 1387446 50 μg
Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.
干预措施: BI 1387446 50 μg (Drug)
Arm A: BI 1387446 100 μg
Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.
干预措施: BI 1387446 100 μg (Drug)
Arm A: BI 1387446 200 μg
Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.
干预措施: BI 1387446 200 μg (Drug)
Arm A: BI 1387446 400 μg
Participants were administered 400 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. The injection volume depended on tumor diameter.
干预措施: BI 1387446 400 μg (Drug)
Arm B: BI 1387446 50 μg / ezabenlimab 240 mg
Participants were administered 50 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
干预措施: BI 754091 (Drug)
Arm B: BI 1387446 100 μg / ezabenlimab 240 mg
Participants were administered 100 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
干预措施: BI 754091 (Drug)
Arm B: BI 1387446 200 μg / ezabenlimab 240 mg
Participants were administered 200 μg of BI 1387446 intratumorally under visual inspection for visible skin tumors or under imaging guidance. BI 754091 (ezabenlimab) was administered intravenously at the recommended phase II dose of 240 mg once every 3 weeks. The maximum duration of ezabenlimab treatment was 34 cycles. BI 1387446 injections were preferably performed after completing the ezabenlimab infusion.
干预措施: BI 754091 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) Based on Number of Dose-limiting Toxicities (DLTs)
时间窗: From first administration of BI 1387446 until to end of treatment cycle 1 (up to 3 weeks).
The MTD in each arm is defined as the highest dose that is expected to cause less than 25% risk of the true DLT rate being above or equal to 33% during the MTD evaluation period. Estimation of the MTD will be based upon the estimation of the posterior probability of the incidence of DLT in toxicity categories during the MTD evaluation period for all evaluable participants. The MTD evaluation period is defined as the time from the first administration of any trial medication to the start of the second treatment cycle. Specifically, this is the time from the first dose to either the second administration of ezabenlimab or the fourth administration of BI 1387446, whichever occurs first. If the second dose of ezabenlimab or the fourth dose of BI 1387446 is not given, the evaluation period ends 90 days after the last administration.
Number of Patients With DLT in the MTD Evaluation Period
时间窗: From first administration of BI 1387446 until to end of treatment cycle 1 (up to 3 weeks).
The MTD evaluation period is defined as the time from the first administration of any trial medication to the start of the second treatment cycle. Specifically, this is the time from the first dose to either the second administration of ezabenlimab or the fourth administration of BI 1387446, whichever occurs first. If the second dose of ezabenlimab or the fourth dose of BI 1387446 is not given, the evaluation period ends 90 days after the last administration.
次要结局
- Objective Response Based on Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)(From start of treatment up to the earliest of progression, death or end of trial (up to 1 year).)
- Objective Response Based on Response Criteria for Intratumoural Immunotherapy in Solid Tumours (itRECIST)(From start of treatment up to the earliest of progression, death or end of trial (approximately 1 year).)
- Best Percentage Change From Baseline in Size of Injected Lesions (CTP Version 1 or 2)(From start of treatment up to the earliest of progression, death or end of trial (approximately 1 year).)
- Best Percentage Change From Baseline in Size of Injected Target Lesions (CTP v3.0 or Later Versions)(From start of treatment up to the earliest of progression, death or end of trial (approximately 1 year).)
- Best Percentage Change From Baseline in Size of Target Lesions (CTP Version 1 or 2)(From start of treatment until the earliest of progression, death or end of trial (approximately 1 year).)
- Best Percentage Change From Baseline in Size of Non-injected Target Lesions (CTP v3.0 or Later Versions)(From start of treatment until the earliest of progression, death or end of trial (approximately 1 year).)