AzTrials
AzTrials

Prostate CancerPhase 1NCT02654938

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

A Phase 1 study testing Mobilan (M-VM3) in people with Prostate Cancer, run by Panacela Labs LLC at 6 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 to 75 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Mobilan (M-VM3)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
6 sitesRussia
Study dates
Jul 2015to Sep 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 34Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Russia6 sites

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

    Moscow

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

    Moscow

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

    Moscow

  • Moscow State University of Medicine and Dentistry

    Moscow

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

    Saint Petersburg

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

    Saint Petersburg

Other trials in Russia

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Mobilan (M-VM3), Placebo
Keywords
prostate cancer, adenovirus, TLR5, immunotherapy
Medical subject headings
Prostatic Neoplasms, Adenoviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • PlaceboDrug

    Also called Dextrose 5%, Glucose 5%

    5% infusion solution of dextrose

Study groups in NCT02654938
Study groupRoleWhat they receive
Mobilan (M-VM3)ExperimentalPatients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Investigational Drug Product
Receives: Drug: Mobilan (M-VM3)
PlaceboPlacebo comparatorPatients with histologically verified non-metastatic prostate cancer (stage 1 or 2) treated with Placebo (Glucose 5%)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline to up to 29 days after the drug administration

Secondary outcomes (7)

  1. Exposure of Mobilan DNA vector in patient's peripheral blood

    Using validated PCR assay

    Measured: Baseline to up to 29 days after the drug administration

  2. Prostate-specific antigen (PSA) measure

    Baseline PSA level will be taken from medical history

    Measured: On Day 29 after the drug administration

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

    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

    Measured: Baseline to up to 29 days after the drug administration

  4. Histopathological assessment of prostate tissue using Gleason grading system (if prostatectomy is made in the study period, and material is available for analysis)

    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.

    Measured: On Day 29 after the drug administration

  5. Presence of protein 502s in blood plasma

    Using ELISA assay

    Measured: Baseline to up to 29 days after the drug administration

  6. Titer of 502 antibodies (AB) in peripheral blood serum

    Using ELISA assay

    Measured: Baseline to up to 29 days after the drug administration

  7. Histopathological assessment of prostate tissue using Irani scale (if prostatectomy is made in the study period, and material is available for analysis)

    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

    Measured: On Day 29 after the drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2016 (estimated)
  2. Study startJul 2015
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02654938
Sponsor's protocol ID
PNC-M-VM3-01
Status last verified
Sep 2017
First submitted
7 Dec 2015
Last updated
20 Sep 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mobilan (M-VM3) in people with Prostate Cancer, run by Panacela Labs LLC at 6 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and intensity of adverse events (according to CTCAE v 4.03 classification) (time frame: Baseline to up to 29 days after the drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02654938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in