An Open Label Phase I PET Imaging Study to Investigate the Bio-distribution and Tumor Uptake of [89Zr]Zr-BI 754111 in Patients With Advanced Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma Treated With BI 754111 in Combination With BI 754091
概览
- 阶段
- 1 期
- 干预措施
- BI 754111
- 疾病 / 适应症
- Carcinoma, Non-Small-Cell Lung
- 发起方
- Boehringer Ingelheim
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 1
- 状态
- 终止
- 最后更新
- 3个月前
概览
简要总结
The main objective of this study is to determine the biodistribution and intra-tumor accumulation of [89Zr]Zr-BI 754111 at baseline and its change upon treatment
研究者
入排标准
入选标准
- •Provision of signed and dated, written Informed Consent Form (ICF) prior to any trial specific procedures, sampling, or analyses
- •Patients of legal age (according to local legislation) at the time of signature of the ICF
- •Patients with histologically confirmed diagnosis of recurrent NSCLC who received anti- PD-1 or anti PD-L1 as Part of last treatment with at least 3 months of stable disease (i.e.patients with confirmed response (PR or CR) regardless of duration of response or stable disease (SD) for a minimum of 3 months) and have become refractory to anti-PD- 1/ anti-PD-L1 based treatment OR
- •-Patients with histologically confirmed diagnosis of recurrent metastatic HNSCC who progressed after platinum based therapy or not indicated for receiving standard (radio) chemotherapy (previous treatment with anti- PD-1/ PD-L1 is allowed)
- •Eastern Cooperative Oncology Group (ECOG, R01-0787) score: 0 to 1
- •Patient must have at least one PET imageable and evaluable tumor lesion of 20mm
- •Patients must have at least one tumor lesion amenable to biopsy. This lesion should be PET imageable and evaluable as defined above and the biopsy should be obtained before first BI 754091 administration, unless medically contra-indicated. In the latter case, 25 4μm sections from an archival biopsy taken at relapse after the previous treatment are acceptable
- •Must have evaluable lesion(s) according to Revised Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and iRECIST
- •Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement
- •Male or female patients. Women of childbearing potential (WOCBP)1 and men able to father a child must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) (that result in a low failure rate of less than 1% per year when used consistently and correctly) during trial Participation and for at least 6 months after the last administration of trial medication. A list of contraception methods meeting these criteria is provided in the patient information.
排除标准
- •Not having fully recovered from major surgery before they enter into the trial according to investigator judgment or planned for major surgery within 12 months after screening, e.g. hip replacement
- •Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- •Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled
- •Previous treatment in this trial
- •Any investigational or anti-tumor treatment within 4 weeks or within 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment.
- •Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 neuropathy due to prior platinum-based therapy
- •Prior treatment with anti-LAG-3 agents
- •Presence of other active invasive cancers other than the one treated in this trial, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment
- •Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may Participate provided they are stable (i.e., without evidence of PD by imaging for at least 4 weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases
- •Inadequate organ function or bone marrow reserve as demonstrated by the laboratory values
研究组 & 干预措施
Part 2: Ezabenlimab 240mg + BI 754111 40mg
干预措施: BI 754111
Part 1: Ezabenlimab 240mg + BI 754111 600mg
干预措施: BI 754111
Part 1: Ezabenlimab 240mg + BI 754111 600mg
干预措施: [89Zr]Zr-BI 754111
Part 1: Ezabenlimab 240mg + BI 754111 600mg
干预措施: BI 754091
Part 2: Ezabenlimab 240mg + BI 754111 40mg
干预措施: [89Zr]Zr-BI 754111
Part 2: Ezabenlimab 240mg + BI 754111 40mg
干预措施: BI 754091
结局指标
主要结局
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 1
时间窗: At 96 hours and 144 hours post-injection of [89Zr]Zr-BI 754111 in each cycle.
The standardized uptake values (SUVs) are calculated as the ratios of the image derived radioactivity concentration upon the whole body concentration of the injected radioactivity, i.e. image derived radioactivity concentration / injected radioactivity concentration upon the whole body - a unitless value since the unit has been cancelled out. The Standard uptake value (SUV) in a 1 milliliter (mL) sphere around highest SUV pixel (SUVpeak) of \[89Zr\]Zr-BI 754111 for tumor uptake for part 1 participants is reported. The SUVpeak (also unitless since it is a SUV value) is summarized for each imaging time point (96hour, 144hour) as the mean tumor uptake over all selected lesions for each treatment cycle, respectively.
Standard Uptake Value (SUV) in a 1ml Sphere Around Highest SUV Pixel (SUVpeak) of [89Zr]Zr-BI 754111 for Tumor Uptake - Part 2
时间窗: At 96 hours and 144 hours post-injection of [89Zr]Zr-BI 754111 in each cycle.
The standardized uptake values (SUVs) are calculated as the ratios of the image derived radioactivity concentration upon the whole body concentration of the injected radioactivity, i.e. image derived radioactivity concentration / injected radioactivity concentration upon the whole body - a unitless value since the unit has been cancelled out. The Standard uptake value (SUV) in a 1 milliliter (mL) sphere around highest SUV pixel (SUVpeak) of \[89Zr\]Zr-BI 754111 for tumor uptake for part 2 participants is reported. The SUVpeak (also unitless since it is a SUV value) is summarized for each imaging time point (96hour, 144hour) as the mean tumor uptake over all selected lesions for each treatment cycle, respectively.