Safety and Tolerability Clinical Trial of Different Doses of the Immunotherapeutic Drug Mobilan (M-VM3) and Placebo in Patients With Prostate Cancer

NCT02654938 | Completed Phase 1

• 1 other identifier: PNC-M-VM3-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; adenovirus; TLR5; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Frequency and intensity of adverse events (according to CTCAE v 4.03 classification)

  Baseline to up to 29 days after the drug administration

Secondary Outcomes (7)

• Exposure of Mobilan DNA vector in patient's peripheral blood

  Baseline to up to 29 days after the drug administration

• Prostate-specific antigen (PSA) measure

  On Day 29 after the drug administration

• Immune cell count in whole blood of patients assessed with flow cytometry

  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)

  On Day 29 after the drug administration

• Presence of protein 502s in blood plasma

  Baseline to up to 29 days after the drug administration

Study Arms (2)

Mobilan (M-VM3)

EXPERIMENTAL

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Investigational Drug Product

Drug: Mobilan (M-VM3)

Placebo

PLACEBO COMPARATOR

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Placebo (Glucose 5%)

Drug: Placebo

Interventions

Mobilan (M-VM3) DRUG

Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s.

Mobilan (M-VM3)

Placebo DRUG

5% infusion solution of dextrose

Also known as: Dextrose 5%, Glucose 5%

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Panacela Labs LLC: lead

Study Sites (6)

Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Sciences

Moscow, Russia

Location

Moscow Scientific Research Institute of Oncology named after P. A. Hertsen of the Ministry of Health of the Russian Federation

Moscow, Russia

Location

Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department

Moscow, Russia

Location

Moscow State University of Medicine and Dentistry

Moscow, Russia

Location

Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"

Saint Petersburg, Russia

Location

Federal State Budgetary Institution "Scientific Research Oncology Institute named after N.N. Petrov" of the Ministry of Health of the Russian Federation

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  PRINCIPAL INVESTIGATOR

• Vladimir M. Moiseenko, MD, PhD

  Federal State Budgetary Institution "Saint Petersburg Clinical Scientific and Practical Center for Special types of medical care (Oncological)"

  PRINCIPAL INVESTIGATOR

• Sergey V. Mishugin, MD, PhD

  Moscow State Budgetary Healthcare Institution "City Clinical Hospital № 57" of Moscow Healthcare Department

  PRINCIPAL INVESTIGATOR

• 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

  PRINCIPAL INVESTIGATOR

• Dmitry Y. Pushkar, MD, PhD

  Moscow State University of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: January 13, 2016
• Study Start: July 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

RU (6)