Spots Global Cancer Trial Database for Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer
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Trial Identification
Brief Title: Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer
Official Title: 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
Study ID: NCT02654938
Conditions
Study Description
Brief Summary: Phase I single-blinded, randomized, placebo-controlled trial evaluating safety, tolerability, pharmacokinetics and pharmacodynamics of single injections of ascending doses of investigational drug product Mobilan (М-VM3) administered directly into the prostate of patients with prostate cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Sciences, Moscow, , Russian Federation
Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation, Moscow, , Russian Federation
Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department, Moscow, , Russian Federation
Moscow State University of Medicine and Dentistry, Moscow, , Russian Federation
Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)", Saint Petersburg, , Russian Federation
Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation, Saint Petersburg, , Russian Federation
Contact Details
Name: Vsevolod B. Matveev, MD, PhD
Affiliation: Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Boris Y. Alexeev, MD, PhD
Affiliation: Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation
Role: PRINCIPAL_INVESTIGATOR
Name: Vladimir M. Moiseenko, MD, PhD
Affiliation: Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"
Role: PRINCIPAL_INVESTIGATOR
Name: Sergey V. Mishugin, MD, PhD
Affiliation: Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department
Role: PRINCIPAL_INVESTIGATOR
Name: Alexander K. Nosov, MD, PhD
Affiliation: Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation
Role: PRINCIPAL_INVESTIGATOR
Name: Dmitry Y. Pushkar, MD, PhD
Affiliation: Moscow State University of Medicine and Dentistry
Role: PRINCIPAL_INVESTIGATOR
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