An open label, Phase I dose-finding and expansion study of BI 765179 as monotherapy and in combination with ezabenlimab (BI 754091) in patients with advanced solid cancers, and BI 765179 in combination with pembrolizumab in first-line PD-L1-positive metastatic or incurable, recurrent head and neck squamous cell carcinoma (HNSCC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 127
- 主要终点
- MTD
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Not currently recruiting, so this is omitted.
- •1.Histologically or cytologically confirmed diagnosis of metastatic or incurable, recurrent HNSCC
- •2.No prior systemic therapy administered in the metastatic or incurable, recurrent setting
- •3.Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
排除标准
- •Not currently recruiting, so this is omitted.
- •1.Disease suitable for local therapy administered with curative intent
- •2.Participants must not have a primary tumor site of nasopharynx or sino-nasal cancer or salivary gland cancers (any histology)
- •3.Life expectancy of <3 months and/or has rapidly progressing disease
结局指标
主要结局
MTD
时间窗: MTD evaluation period
The MTD, defined as the highest dose with less than 25% risk of the true DLT rate being equal to or above 33% during the MTD evaluation period. The MTD will be assessed based on the number of patients experiencing DLTs, graded according to CTCAE version 5.0, during the MTD evaluation period.
Number of patients experiencing DLTs
时间窗: MTD evaluation period
Number of patients experiencing DLTs in the MTD evaluation period.
Objective response (OR)
时间窗: From the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent
Objective response (OR), defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1 by Investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
次要结局
- Number of patients experiencing DLTs during the on-treatment period(on-treatment period)
- Cmax(,ss)
- AUC0-504(,ss)
- Occurence of AEs during the on-treatment period(on-treatment period)
- Occurence of SAEs during the on-treatment period(on-treatment period)
- OR assessed by the Investigator according to iRECIST(from the first administration of study medication until the end of treatment)