A Multicenter Randomized Double-blind Placebo-controlled Pilot Study of Safety, Pharmacodynamics and Efficacy of Different Treatments of Immunotherapeutic Drug Mobilan (M-VM3) in Patients With Diagnosed Prostate Cancer

NCT02844699 | Unknown Phase 1

• 1 other identifier: PNC-M-VM3-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

Brief Summary

A Phase Ib2, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study evaluating different regimens of the immunotherapeutic drug, Mobilan (M-VM3), in patients with prostate cancer.

Conditions

Prostate Cancer

Keywords

prostate cancer; adenovirus; TLR5; immunotherapy; Ad5

Outcome Measures

Primary Outcomes (2)

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

  Baseline to up to 45 days after the first drug administration

• Counting of CD4+ and CD8+ cells in prostate biopsy and surgery samples

  Using immunological assays

  Baseline to up to 45 days after the first drug administration

Secondary Outcomes (7)

• Change in total Prostate-specific antigen (PSA) level

  Baseline to up to 45 days after the first drug administration

• Value of the Irani score of post-operative prostate tissue (if material is available for analysis)

  On Day 30 after the first drug administration

• Value of the Gleason score of post-operative prostate tissue (if material is available for analysis)

  On Day 30 after the first drug administration

• Plasma concentration of inflammatory cytokines

  Baseline to up to 45 days after the first drug administration

• Presence of protein 502s in blood plasma

  Baseline to up to 45 days after the first drug administration

Study Arms (3)

Mobilan (M-VM3) on both Day 1 and on Day 15

EXPERIMENTAL

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 3) treated with Investigational Drug Product (Mobilan (M-VM3)) administered 2 weeks apart. All subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.

Drug: Mobilan (M-VM3)

Placebo on Day 1 and Mobilan (M-VM3) on Day 15

EXPERIMENTAL

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 3) treated with Placebo (Glucose 5%) first on Day 1 and Investigational Drug Product (Mobilan (M-VM3)) in two weeks on Day 15. All subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.

Drug: Mobilan (M-VM3); Drug: Placebo

Placebo on both Day 1 and Day 15

PLACEBO COMPARATOR

Patients with histologically verified non-metastatic prostate cancer (stage 1 or 3) treated with Placebo (Glucose 5%) administered 2 weeks apart. All subjects will subsequently undergo planned prostatectomy, ideally within 2 weeks following the final study drug injection and will remain under observation thereafter.

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) on both Day 1 and on Day 15; Placebo on Day 1 and Mobilan (M-VM3) on Day 15

Placebo DRUG

5% infusion solution of dextrose (glucose)

Also known as: Dextrose 5%, Glucose 5%

Placebo on Day 1 and Mobilan (M-VM3) on Day 15; Placebo on both Day 1 and Day 15

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-Т3, 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 sequel
• 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 (4)

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; Alzheimer Disease 5

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 Design

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

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 26, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

RU (4)