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Safety and Immune Response to FMPV-1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05238558
Recruitment Status : Active, not recruiting
First Posted : February 14, 2022
Last Update Posted : July 11, 2022
Sponsor:
Collaborator:
Quotient Sciences
Information provided by (Responsible Party):
Hubro Therapeutics AS

Brief Summary:
This is a single centre, open-label, non-randomized, Phase I study assessing safety and immune response of FMPV-1 in healthy male subjects.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: FMPV-1 Biological: GM-CSF (as adjuvant) Phase 1

Detailed Description:

To date, there is no clinical experience with FMPV-1. This is the first clinical study with FMPV-1 in healthy volunteers to assess the safety and immunogenicity of FMPV-1 in man. The study population will include 16 healthy males in 2 cohorts (8 per cohort) to ensure data in a minimum of 14 subjects.

Up to two dose levels of FMPV-1 in conjunction with the adjuvant granulocyte macrophage colony stimulating factor (GM-CSF) will be assessed - the dose in Cohort 2 will depend on the safety and specific delayed type hypersensitivity (DTH) response data from Cohort 1. Each cohort will follow the same study design. Following preliminary screening procedures, subjects will be admitted in the morning on the day before initial dosing (Day -1). In Cohorts 1 and 2, subjects will receive FMPV-1 15 ± 5 min after GM-CSF on Days 1, 8, 15, 29 and 43 as an intradermal injection into the back of the upper arm. In Cohort 1, 8 subjects will receive GM-CSF (0.03 mg) + FMPV-1 (0.15 mg/injection: low dose) administered as 2 separate intradermal injections. In Cohort 2, 8 subjects will receive GM-CSF (0.03 mg) + FMPV-1 (either 0.15 or 0.3 mg/injection - dependent on Cohort 1 data) administered as 2 separate intradermal injections.

Sentinel dosing will be applied for both cohorts if different doses are used; if the same dose is to be used in both cohorts, sentinel dosing will not be applied in Cohort 2.

Adverse events and laboratory assessments will be the endpoints to assess the safety of GM-CSF/FMPV-1 vaccination. FMPV-1 specific DTH responses and FMPV-1-specific proliferative T-cell responses will be the endpoints to assess the FMPV-1 specific immune response. Subjects will receive a total of 8 administrations intradermally: GM-CSF + FMPV-1 on 5 separate occasions and FMPV-1 (without GM-CSF) on 3 occasions for the DTH skin reactivity assessment. The main part of the study will last for approximately 16 weeks, including screening, and subjects will return for follow-up visits after 6 months and 12 months. The overall estimated time from screening until the final follow-up visit is approximately 12 months. All adverse reactions will be collected until early withdrawal or discharge from the study after the 12-month follow-up visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of FMPV-1 in Healthy Male Subjects to Assess Safety and Immune Response
Actual Study Start Date : January 31, 2022
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: FMPV-1 vaccination

GM-CSF (0.03 mg) + FMPV-1 (0.15 mg/injection: low dose) administered as 2 separate intradermal injections.

Total of 8 administrations intradermally; GM-CSF + FMPV-1 on 5 separate occasions and FMPV-1 (without GM-CSF) on 3 occasions for the DTH skin reactivity assessment.

Biological: FMPV-1
Intradermal administration

Biological: GM-CSF (as adjuvant)
Intradermal administration




Primary Outcome Measures :
  1. Delayed Type Hypersensitivity Skin Reactivity Test [ Time Frame: 45 days ]
    DTH test performed on Days 3, 29 and 43 with response assessment on Days 8, 31 and 45. A positive DTH response will be recorded if the area of the skin reaction (redness and/or induration) at the injection site has an average diameter ≥5 mm 48 h after injection.

  2. Proliferative T-cell Responses [ Time Frame: 12 months ]
    Whole Blood Samples for Proliferative T-cell Responses taken on Days 1, 45, 57±1, 80±3, 6-month and 12-month follow-ups. Samples will be processed to isolate PBMCs for T-cell receptor analysis.

  3. Summary of Adverse Events [ Time Frame: 12 months ]
    An AE is any untoward medical occurrence in a subject that occurs either before dosing (referred to as a pre-dose AE) or once a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product. AEs will be monitored from the time the subject signs the ICF until after the 12-month follow-up visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males
  2. Aged 18 to 55 years inclusive at the time of signing informed consent
  3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
  4. Must provide written informed consent
  5. Must agree to adhere to the contraception requirements: male subjects who are sexually active with a partner of childbearing potential must use a condom plus an approved method of highly effective contraception from the time of informed consent until 90 days (one cycle of spermatogenesis) after last vaccine administration.

Exclusion Criteria:

  1. Subjects who have received any investigational medicinal product in a clinical research study within the 90 days prior to Day 1 or within less than 5 elimination half-lives prior to Day 1, whichever is longer
  2. Subjects who are, or are immediate family members of, a study site or sponsor employee
  3. Subjects who have previously been administered investigational medicinal product in this study.
  4. Evidence of current SARS-CoV-2 infection
  5. History of any drug or alcohol abuse in the past 2 years
  6. Regular alcohol consumption defined as >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
  7. A confirmed positive alcohol breath test at screening or admission
  8. Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
  9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months
  10. Subjects with pregnant or lactating partners
  11. Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.
  12. Confirmed positive drugs of abuse test result
  13. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
  14. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
  15. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  16. Presence or history of a clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
  17. Subjects currently receiving any agent with a known effect on the immune system within 90 days before first investigational medicinal product administration
  18. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
  19. Subjects who are taking, or have taken, any prescribed or over-the-counter medications, herbal remedies or antihistamines (other than vitamin supplements and/or up to 4 g of paracetamol per day) in the 7 days before investigational medicinal product administration
  20. Subjects who have had a vaccine (including COVID-19 vaccine) within 28 days before first dose
  21. Subjects with tattoos or scars on the arms which may interfere with injection site assessments, as determined by the investigator or delegate at screening
  22. Subjects with any other illnesses or medical conditions such as, but not limited to:

    • Any infection that requires systemic treatment (any grade)
    • Cardiac failure (any grade)
    • Systemic and gastrointestinal inflammatory conditions
    • Bone marrow dysplasia
    • History of auto-immune disease
    • History of adverse reactions to any vaccines
    • History of adverse reactions to GM-CSF
  23. Subjects with any other malignancies within the last 3 years (except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer)
  24. Subjects planning to receive a yellow fever or other live (attenuated) vaccine during the course of study
  25. Subject has a first degree relative with a haematological malignancy
  26. Failure to satisfy the investigator of fitness to participate for any other reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05238558


Locations
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United Kingdom
Quotient Sciences
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Hubro Therapeutics AS
Quotient Sciences
Investigators
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Principal Investigator: Nand Singh Quotient Sciences
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Responsible Party: Hubro Therapeutics AS
ClinicalTrials.gov Identifier: NCT05238558    
Other Study ID Numbers: FMPV-1-01
QSC204718 ( Other Identifier: Quotient )
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hubro Therapeutics AS:
FMPV-1
Cancer-specific vaccine
Neoantigen
GM-CSF adjuvant
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases