Phase I Open-label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 190
- 试验地点
- 28
- 主要终点
- Part 2.2, Dose Expansion: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed partial response (iPR)
研究概览
简要总结
This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people 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 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time.
This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle.
Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors 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
- 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
- •Histologically or cytologically confirmed diagnosis of advanced, unresectable and/or metastatic or relapsed/refractory solid tumors
- •At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., image guided procedures) for both biopsies and injections of BI 1831169
- •Has failed conventional treatment or for whom no therapy of proven efficacy exists, who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part
- •Further inclusion criteria apply.
排除标准
- •Previous treatment with Vesicular stomatitis virus (VSV)-based agents
- •Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
- •Presence of brain metastases
- •Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
- •Chronic steroid use, regardless of daily dose Further exclusion criteria apply.
研究组 & 干预措施
Part 1 (Monotherapy): Arm B
干预措施: BI 1831169 (Drug)
Part 2 (Combination therapy): Arm E
干预措施: BI 1831169 (Drug)
Part 2 (Combination therapy): Arm D
干预措施: anti-PD-1 antibody (Drug)
Part 2 (Combination therapy): Arm E
干预措施: anti-PD-1 antibody (Drug)
Part 2 (Combination therapy): Arm D
干预措施: BI 1831169 (Drug)
Part 1 (Monotherapy): Arm A
干预措施: BI 1831169 (Drug)
Part 1 (Monotherapy): Arm C
干预措施: BI 1831169 (Drug)
结局指标
主要结局
Part 2.2, Dose Expansion: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed partial response (iPR)
时间窗: up to 49 months
BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST) by Investigator's assessment. BOR will consider all tumor assessments from first administration of trial medication until disease progression, death, last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent (whichever occurs first).
Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period
时间窗: up to 21 days
Part 1 (Monotherapy).
Part 1.2, Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)
时间窗: up to 49 months
BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST). BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period
时间窗: up to 21 days
Part 2 (Combination Therapy).
Part 2.2, Dose Expansion, Arm D: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)
时间窗: up to 49 months
BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST). BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
Part 2.2, Dose Expansion, Arm E, Arm F, Arm G: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed immunotherapy partial response (iPR)
时间窗: up to 49 months
BOR is defined according to Response Criteria for intravenous Immunotherapy in Solid Tumors (iRECIST). BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.
次要结局
- Part 1.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period(up to 49 months)
- Part 1.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period(up to 49 months)
- Part 1.2, Dose expansion: Occurrence of adverse events during the on-treatment period(up to 49 months)
- Part 1.2, Dose expansion: Occurrence of DLTs during the mono MTD evaluation period(up to 49 months)
- Part 2.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period(up to 49 months)
- Part 2.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period(up to 49 months)
- Part 2.2 - Dose Expansion by Indication, All Arms: Occurrence of adverse events during the on-treatment period(up to 49 months)
- Part 2.2 - Dose Expansion by Indication, Arm D: Duration of objective response (DoR)(up to 49 months)
- Part 2.2, Dose Expansion by Indication, Arm D: Disease control (DC)(up to 49 months)
- Part 2.2, Dose Expansion by Indication, Arms E, F, G: Duration of objective response (DoR)(up to 49 months)
- Part 2.2, Dose Expansion by Indication, Arms E, F, G: Disease control (DC)(up to 49 months)
- Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months(up to 4 months)
- Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)(up to 49 months)
- Part 2.2, Dose Expansion by Indication, Arms D and E: Disease control (DC)(up to 49 months)
- Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months (PFS-4)(up to 4 months)