Phase I Open-label Dose Escalation Trial of BI 3923948 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced, Unresectable and/or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Occurrence of Dose-limiting toxicities (DLTs) during the primary DLT evaluation period
研究概览
简要总结
This study is open to adults aged 18 and over or above legal age with different types of recurrent advanced cancer (solid tumors) that have spread to other parts of the body and that are accessible for injection and biopsy. This is a study for people for whom previous treatment was not successful or no treatment exists, with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 3923948, that people with advanced cancer can tolerate, when taken alone and together with a type of antibody called a checkpoint inhibitor (anti-programmed cell death protein 1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 3923948 is given to people for the first time.
This study has 2 arms. In Arm A, participants get BI 3923948 alone for up to 3 months. In Arm B, participants get BI 3923948 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 3923948 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 3923948 is given as injection(s) into the tumor, and the checkpoint inhibitor is given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Only in treatment cycle 1 will participants get BI 3923948 twice in the first week.
Participants visit the site study site regularly. The number of study visits vary based on the study arm and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors closely check the health of the participants and also take note of any health problems that could have been caused by the study treatment.
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
- •Measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- •Patient has 1 or more accessible lesions (2 or more preferred)
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- •Life expectancy of at least ≥3 months after the start of the treatment according to the investigator's judgement Further inclusion criteria apply.
排除标准
- •Patients with known primary brain tumors, leptomeningeal disease or untreated brain metastases. Subjects with previously treated brain metastases may participate provided the brain metastases are stable
- •Previous treatment with vesicular stomatitis virus (VSV)-based agents
- •Concomitant medication or condition considered a high risk for complications from injection
- •History of common terminology criteria for adverse events (CTCAE) v5 grade 3 or higher severe hypersensitivity reactions to previous anti-programmed cell death 1 (anti-PD-1)/anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) (Arm B only) Further exclusion criteria apply.
研究组 & 干预措施
Arm B: BI 3923948 in combination with ezabenlimab
干预措施: Ezabenlimab (Drug)
Arm A: BI 3923948 monotherapy
干预措施: BI 3923948 (Drug)
Arm B: BI 3923948 in combination with ezabenlimab
干预措施: BI 3923948 (Drug)
结局指标
主要结局
Occurrence of Dose-limiting toxicities (DLTs) during the primary DLT evaluation period
时间窗: up to 3 weeks
次要结局
- Occurrence of DLTs during the on-treatment period(up to 12 months)
- Occurrence of Adverse Events (AEs) during the on-treatment period(up to 12 months)