Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer
Multicenter, Randomized, Single-blind Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer
研究概览
详细说明
Mobilan is a type V adenovirus carrying TLR5 receptor and its agonist, protein 502s. It's mechanism of action involves activation of immune system and extensive mobilisation of various immunocytes to administration locus. It's safety and tolerability is currently evaluated in first-in-man phase I study in prostate cancer patients. Treatment strategy for the disease (radical prostatectomy or active observation) will be determined by the Investigator in accordance with routine clinical practice of the hospital.
Patients will be randomised in cohorts of 4 subjects, where 3 subjects will be administered with Mobilan (М-VM3), and one patient will be administered with placebo.
The dose will be escalated from cohort to cohort, the decision on possible dose escalation will be made by Independent Safety Review Board.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
-
Moscow、俄罗斯联邦
- Moscow State University of Medicine and Dentistry
-
Moscow、俄罗斯联邦
- Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department
-
Moscow、俄罗斯联邦
- Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Sciences
-
Moscow、俄罗斯联邦
- Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation
-
Saint Petersburg、俄罗斯联邦
- Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"
-
Saint Petersburg、俄罗斯联邦
- Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subscribed Informed consent for participation in the trial
- Men aged 45 to 75 years
- Patients with histologically verified prostate cancer, stage Т1-Т2, N0, M0
- Patient's ECOG status 0-2
- Negative tests for serologic markers of HIV-infection, viral hepatitis В and С, syphilis Patient and his partner should agree to use barrier contraception throughout the study period
Exclusion Criteria:
- Failure to obtain Informed consent
- Clinical or radiological signs of metastases
- Indication to hormone therapy of prostate cancer
Clinically significant cardiovascular diseases:
- Myocardial infarction within 6 months prior the screening
- Unstable stenocardia within 3 months prior the screening
- Severe circulation failure (FC III)
- Clinically significant arrhythmias
- Hypotension (systolic blood pressure < 86 mm Hg) or bradycardia with HR < 50 beats per min.
- Uncontrolled arterial hypertension (systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg.)
- Clinically significant CNS diseases at the screening
- Current infection or another severe or systemic disease which increases risk of treatment sequelae
- Pituitary gland or adrenal disorders in medical history
- Other malignant tumors within the last 5 years
- Other concomitant diseases in medical history which according to Investigator may aggravate during the study, including uncontrolled diabetes mellitus, rectal diseases, rectal fissures, hemorrhoid, rectal polyps, rectostenosis, inflammatory urinary diseases: chronic prostatitis, cystitis, urethral catheter, chronic urine retention.
- Complicated allergic history, systemic allergic reaction, any dietary allergy, intolerability, limitations or specific diets which according to the Investigator may be a contraindication for subject participation in the present study.
- Administration of drug products which have a marked effect on immune system within 3 previous months prior the screening, long-term intake of disaggregants (warfarin, low molecular heparin except for ThromboASS).
- Participation in other clinical studies or administration of investigational drug products within 30 days prior the screening, or persisting adverse reactions of any investigational drug product.
- Any clinically significant patient's health disorders and/or laboratory abnormalities not enlisted in the Protocol which are identified at the screening, and/or any reason which according to the Investigator may prevent the patient's participation in the study.
- Drug or alcohol abuse at the screening or in the past which according to the Investigator makes the patient ineligible for participation in the study: intake of more than 5 units of alcohol a week (1 unit of alcohol is equivalent to ½ liter of beer, 200 ml of vine or 50 ml of alcohol) or anamnestic data on alcoholism, narcomania, drug abuse and/or history of significant alcohol or drug abuse inducing drug dependence, within one year prior the screening visit.
- Vaccination made 14 days prior the study
- Smoking of more than 10 cigarettes a day
- Unability to understand or follow study instructions
- Lack of availability during 29 days after administration of the investigational drug product, fails to follow visit schedule
- Individual intolerability of the investigational drug product components
Study withdrawal criteria:
- Any patient may refuse from the study participation on his own wish in any moment on any study stage.
Principal Investigator may withdraw any patient from the study in the following cases:
- Investigator makes the decision that a patient should be withdrawn in his own best interests
- Patient develops any serious adverse reactions/events in the screening period
- Patient has been enrolled to the study with violations, or does not follow the protocol requirements
- Patient needs additional treatment in the screening period
- Sponsor has right to terminate the study in any moment.
- Regulatory authorities have right to terminate the study in any moment.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Mobilan (M-VM3)
Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Investigational Drug Product
|
Mobilan (M-VM3),基于非复制腺病毒递送系统的创新实验药物,由编码 TLR5 受体及其配体 502s 的基因组载体组成。
|
安慰剂比较:Placebo
Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Placebo (Glucose 5%)
|
5% infusion solution of dextrose
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Frequency and intensity of adverse events (according to CTCAE v 4.03 classification)
大体时间:Baseline to up to 29 days after the drug administration
|
Baseline to up to 29 days after the drug administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Exposure of Mobilan DNA vector in patient's peripheral blood
大体时间:Baseline to up to 29 days after the drug administration
|
Using validated PCR assay
|
Baseline to up to 29 days after the drug administration
|
Prostate-specific antigen (PSA) measure
大体时间:On Day 29 after the drug administration
|
Baseline PSA level will be taken from medical history
|
On Day 29 after the drug administration
|
Immune cell count in whole blood of patients assessed with flow cytometry
大体时间:Baseline to up to 29 days after the drug administration
|
Including leucocytes, lymphocytes, T-lymphocyte, leukocyte index, total T-lymphocytes, CD3, T-helper cells CD3 + CD4 +, T-cytotoxic CD3 + CD8 +, regulation index (CD4 / CD8), double-cells CD4 + / CD8 +, NK cells CD3-CD (16 + 56) +, TNK-cells CD3 + CD (16 +56) +, B-lymphocytes CD19 +, 0-lymphocytes
|
Baseline to up to 29 days after the drug administration
|
Histopathological assessment of prostate tissue using Gleason grading system (if prostatectomy is made in the study period, and material is available for analysis)
大体时间:On Day 29 after the drug administration
|
The Gleason grading system is used to evaluate the stage of prostate cancer using samples from biopsy or post-surgical samples as follow: 1 - The cancerous prostate closely resembles normal prostate tissue. 2 - The tissue still has well-formed glands, but they are larger and have more tissue between them. 3 - The tissue still has recognizable glands, but the cells are darker. 4 - The tissue has few recognizable glands. 5 - The tissue does not have any or only a few recognizable glands. |
On Day 29 after the drug administration
|
Presence of protein 502s in blood plasma
大体时间:Baseline to up to 29 days after the drug administration
|
Using ELISA assay
|
Baseline to up to 29 days after the drug administration
|
Titer of 502 antibodies (AB) in peripheral blood serum
大体时间:Baseline to up to 29 days after the drug administration
|
Using ELISA assay
|
Baseline to up to 29 days after the drug administration
|
Histopathological assessment of prostate tissue using Irani scale (if prostatectomy is made in the study period, and material is available for analysis)
大体时间:On Day 29 after the drug administration
|
Irani J (1997) scale include histological assessment of slide mounts obtained after operation as follow: Degree of immune cell infiltration: 0 - No inflammatory cells, 1 - Scattered inflammatory cell infiltrate within the stroma without lymphoid nodules, 2 - Nonconfluent lymphoid nodules, 3 - Large inflammatory areas with confluence of infiltrate |
On Day 29 after the drug administration
|
合作者和调查者
调查人员
- 首席研究员:Vsevolod B. Matveev, MD, PhD、Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Medical Sciences
- 首席研究员:Boris Y. Alexeev, MD, PhD、Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation
- 首席研究员:Vladimir M. Moiseenko, MD, PhD、Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"
- 首席研究员:Sergey V. Mishugin, MD, PhD、Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department
- 首席研究员:Alexander K. Nosov, MD, PhD、Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation
- 首席研究员:Dmitry Y. Pushkar, MD, PhD、Moscow State University of Medicine and Dentistry
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
美比兰 (M-VM3)的临床试验
-
Panacela Labs LLC未知
-
University of OxfordIfakara Health Institute招聘中
-
University of the Incarnate Word59th Medical Wing; United States Naval Medical Center, San Diego; Madigan Army Medical Center; Joint... 和其他合作者完全的
-
Fundació Institut de Recerca de l'Hospital de la...Sheba Medical Center; iMinds; Semmelweis University; AQuAS, Agència de Qualitat i Avaluació Sanitàries完全的
-
University of OxfordBill and Melinda Gates Foundation; University Hospitals Bristol and Weston NHS Foundation Trust招聘中