NCT04550897终止1 期
A Phase 1/2 Study With BM7PE Immunotoxin in Colorectal Cancer Patients With Metastatic Disease Who Are Refractory to or With Intolerance to Last Line of Standard Chemotherapy.
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Adverse Events related to BM7PE
研究概览
简要总结
This phase 1/2 study will evaluate the safety, tolerance and dose of BM7PE treating patients with colorectal cancer who have progressed to standard cell therapy or cannot tolerate such therapy. The study starts as a phase 1 study with the aim of assessing the final recommended dose of BM7PE for this group of patients. Based on the results, the study will continue into a phase 2. The phase 2 study aim to examine overall survival ≥ 9.3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 verified adenocarcinoma of colon or rectum
- •Ambulatory with an ECOG performance status 0-1
- •At least 18 years of age
- •Progressive disease on or last line of standard chemotherapy or intolerance to further chemotherapy
- •Laboratory values as the following: ANC, Platelets, Hb, Creatinine, Bilirubin, ASAT, ALAT, Albumin levels, INR
- •Signed informed consent and expected cooperation of the patients for the treatment, and follow-up must be obtained and documented according to ICH GCP, and national/local regulations
排除标准
- •History of prior metastatic disease the last 3 years
- •History of CNS or bone metastases
- •Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
- •Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
- •Alcohol or drug abuse
- •Any reason why, in the opinion of the investigator, the patient should not participate
- •Has a known history of Human Immunodeficiency Virus (HIV)
- •Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
- •Is pregnant or breastfeeding, or expecting to conceive or father children within the project duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
结局指标
主要结局
Adverse Events related to BM7PE
时间窗: 30 days after last dose of BM7PE
To characterize the safety and toxicity of BM7PE by register adverse event in accordance with CTCAE 5.0
次要结局
- Radiological response to BM7PE(From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
- Efficacy of the BM7PE: Overall survival(Through study completion, an average of 1 year)
- Efficacy of the BM7PE: progression free survival(From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
研究者
Geir Olav Hjortland
MD PhD
Oslo University Hospital
研究点 (2)
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