Safety and Immune Response to FMPV-1

NCT05238558 | Completed Phase 1

• 2 other identifiers: FMPV-1-01QSC204718
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

FMPV-1; Cancer-specific vaccine; Neoantigen; GM-CSF adjuvant

Outcome Measures

Primary Outcomes (3)

• Delayed Type Hypersensitivity Skin Reactivity Test

  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.

  45 days

• Proliferative T-cell Responses

  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.

  12 months

• Summary of Adverse Events

  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.

  12 months

Study Arms (1)

FMPV-1 vaccination

EXPERIMENTAL

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; Biological: GM-CSF (as adjuvant)

Interventions

FMPV-1 BIOLOGICAL

Intradermal administration

FMPV-1 vaccination

GM-CSF (as adjuvant) BIOLOGICAL

Intradermal administration

FMPV-1 vaccination

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Aged 18 to 55 years inclusive at the time of signing informed consent
• Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening
• Must provide written informed consent
• 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.

You may not qualify if:

• 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
• Subjects who are, or are immediate family members of, a study site or sponsor employee
• Subjects who have previously been administered investigational medicinal product in this study.
• Evidence of current SARS-CoV-2 infection
• History of any drug or alcohol abuse in the past 2 years
• 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)
• A confirmed positive alcohol breath test at screening or admission
• 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
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months
• Subjects with pregnant or lactating partners
• Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.
• Confirmed positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
• History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

Sponsors & Collaborators

• Hubro Therapeutics AS: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

Related Publications (1)

• Inderberg EM, Singh N, Miller R, Arbe-Barnes S, Eriksen HK, Lversen B, Juul HV, Eriksen JA, Handeland KR. Generation of frameshift-mutated TGFbetaR2-specific T cells in healthy subjects following administration with cancer vaccine candidate FMPV-1/GM-CSF in a phase 1 study. Cancer Immunol Immunother. 2025 Feb 25;74(4):115. doi: 10.1007/s00262-025-03969-6.

  PMID: 39998682 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Nand Singh

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 14, 2022
• Study Start: January 31, 2022
• Primary Completion: October 31, 2022
• Study Completion: June 30, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)