Multicenter, Open-label, Exploratory Phase I Pilot Study to Investigate Safety, Pharmacodynamics, and Pharmacokinetics of Immunological Effects and Activity of Combining Multiple Doses of IMAB362 With Immunomodulation (Zoledronic Acid, Interleukin-2) in Patients With Advanced Adenocarcinoma of the Stomach, the Lower Esophagus, or the Gastroesophageal Junction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 9
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced gastroesophageal cancer.
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
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 confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
- •Inoperable locally advanced disease, resections with R0, R1 or R2 outcome or metastatic disease.
- •CLDN18.2 expression confirmed by immunohistochemistry in paraffin embedded tumor tissue sample.
- •Measurable and/or non-measurable disease as defined according to RECIST v1.1
- •Age ≥ 18 years
- •Written informed consent
- •ECOG performance status (PS) 0-1
- •Life expectancy > 3 months
排除标准
- •Prior hypersensitivity reaction or intolerance to one of the compounds of the study treatment
- •Known HIV infection or known symptomatic hepatitis (A, B, C)
- •Clinical symptoms of cerebral metastases
- •Pregnancy or breastfeeding
- •Patients treated with any bisphosphonate-based therapeutic for any indication during the previous year
- •Hypocalcemia that requires medication. Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL (3.0 mmol/L)
研究组 & 干预措施
IMAB362 + ZA
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1.
干预措施: IMAB362 (Drug)
IMAB362 + ZA
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1.
干预措施: Zoledronic acid (Drug)
IMAB362 + ZA + IL-2 (1 million IU)
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.
干预措施: IMAB362 (Drug)
IMAB362 + ZA + IL-2 (1 million IU)
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.
干预措施: Zoledronic acid (Drug)
IMAB362 + ZA + IL-2 (1 million IU)
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.
干预措施: Interleukin-2 (1 million IU) (Drug)
IMAB362 + ZA + IL-2 (3 million IU)
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.
干预措施: IMAB362 (Drug)
IMAB362 + ZA + IL-2 (3 million IU)
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.
干预措施: Zoledronic acid (Drug)
IMAB362 + ZA + IL-2 (3 million IU)
Participants received IMAB362 on Day 1 of each 3-week cycle (every 3 weeks). Participants received ZA on Day 1 and IL-2 on Days 1 to 3 of Cycles 1 and 3 only.
干预措施: Interleukin-2 (3 million IU) (Drug)
IMAB362
Participants received IMAB362 only on Day 1 of each cycle every 3 weeks.
干预措施: IMAB362 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: at least 18 months
Descriptive statistics for treatments will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.
Immune cell profile and kinetics
时间窗: at least 18 months
Descriptive statistics for treatments will be given on the number and activity of immune cells in peripheral blood of patients.
次要结局
- Progression-free survival (PFS)(at least 18 months)
- Duration of response (DOR)(at least 18 months)
- Objective tumor response rate (ORR)(at least 18 months)
- Disease control rate (DCR)(at least 18 months)