A First-in-human, Open-label, Phase I Trial to Determine the Safety and Tolerability of BI 3822971 in Patients With Unresectable Advanced or Metastatic Solid Cancers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 137
- 试验地点
- 20
- 主要终点
- Occurrence of treatment-emergent adverse events (AEs)
研究概览
简要总结
This study is open to adults with advanced or metastatic solid cancer, such as non-small cell lung cancer, head and neck squamous cell carcinoma, triple-negative breast cancer, esophageal squamous cell carcinoma, bladder cancer, vulvar cancer, and cervical cancer. People can join the study if they have no remaining standard treatment options and have a measurable lesion outside the central nervous system. The purpose of this study is to find out how well a medicine called BI 3822971 is tolerated in people with these cancers. Researchers also want to find a dose and dosing schedule of BI 3822971 that is safe and is well tolerated.
In this study, BI 3822971 is given to humans for the first time. BI 3822971 is being developed to help the immune system fight cancer. This schedule can change during the course of the trial depending on the data generated. All participants receive the study medicine (there is no randomization and no placebo group). Participants visit the study site and may need to stay overnight for observation, especially on days when the medicine is administered.
Participants can stay in the study for up to 3 years as long as they benefit from treatment and can tolerate it. During this time, doctors regularly check the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects. They collect information on any health problems of the participants and take blood samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients must have histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), esophageal squamous cell cancer (ESCC), bladder cancer (BC), vulvar cancer (VC) and cervical cancer (CC) and have no remaining standard treatment options (including those who have failed or are intolerant to standard therapy).
- •Patients ≥18 years of age and over the legal age of consent as required by local legislation at the time of signature of the informed consent form (ICF).
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Patient must have at least one measurable lesion outside of the central nervous system (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
- •Tumour lesions that have been irradiated ≥28 days before the start of treatment, and have subsequently had documented progression, may be chosen as measurable lesions only in the absence of measurable lesions that have not been irradiated.
- •Further inclusion criteria apply.
排除标准
- •Prior treatment with systemic anticancer drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of study intervention.
- •Treatment with extensive field radiotherapy including whole brain irradiation within 14 days prior to first administration.
- •Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV).
- •History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of III or IV, corrected QT (QTc) prolongation > 480 msec, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the Investigator.
- •Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to treatment.
- •Further exclusion criteria apply.
研究组 & 干预措施
Dose escalation (all participants)
干预措施: BI 3822971 (Drug)
结局指标
主要结局
Occurrence of treatment-emergent adverse events (AEs)
时间窗: up to 36 months
Occurrence of dose limiting toxicities (DLTs)
时间窗: up to 36 months
次要结局
- Maximum measured concentration (Cmax) of BI 3822971 in plasma(up to 36 months)
- Area under the concentration-time curve (AUC) of BI 3822971 in plasma(up to 36 months)