Colorectal CancerPhase 1NCT05238558
Safety and Immune Response to FMPV-1
A Phase 1 study testing FMPV-1 and GM-CSF (as adjuvant) in people with Colorectal Cancer, run by Hubro Therapeutics AS at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FMPV-1 and GM-CSF (as adjuvant)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jan 2022to 30 Jun 2023
- 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 33Show fewer
- 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
- Presence or history of a clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Subjects currently receiving any agent with a known effect on the immune system within 90 days before first investigational medicinal product administration
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- 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
- Subjects who have had a vaccine (including COVID-19 vaccine) within 28 days before first dose
- Subjects with tattoos or scars on the arms which may interfere with injection site assessments, as determined by the investigator or delegate at screening
- 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
- 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)
- Subjects planning to receive a yellow fever or other live (attenuated) vaccine during the course of study
- Subject has a first degree relative with a haematological malignancy
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of FMPV-1 in Healthy Male Subjects to Assess Safety and Immune Response
This is a single centre, open-label, non-randomized, Phase I study assessing safety and immune response of FMPV-1 in healthy male subjects.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- FMPV-1, GM-CSF (as adjuvant)
- Keywords
- FMPV-1, Cancer-specific vaccine, Neoantigen, GM-CSF adjuvant
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMPV-1Biological
Intradermal administration
GM-CSF (as adjuvant)Biological
Intradermal administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: FMPV-1; Biological: GM-CSF (as adjuvant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start31 Jan 2022
- Primary completion31 Oct 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hubro Therapeutics AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Nand Singh, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238558
- Sponsor's protocol ID
- FMPV-1-01
- Other IDs
- QSC204718
- Status last verified
- Sep 2023
- First submitted
- 26 Jan 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39998682
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of FMPV-1 in Healthy Male Subjects to Assess Safety and Immune Response
- ClinicalTrials.gov ID
- NCT05238558
- Acronym / sponsor ID
- FMPV-1-01
- Conditions
- Colorectal Cancer
- Keywords
- FMPV-1, Cancer-specific vaccine, Neoantigen, GM-CSF adjuvant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hubro Therapeutics ASIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single centre, open-label, non-randomized, Phase I study assessing safety and immune response of FMPV-1 in healthy male subjects.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMPV-1 vaccination | Experimental | Biological: FMPV-1, Biological: GM-CSF (as adjuvant)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMPV-1Intradermal administration | Biological | FMPV-1 vaccination |
| GM-CSF (as adjuvant)Intradermal administration | Biological | FMPV-1 vaccination |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 39998682Inderberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nand Singh principal investigator
Quotient Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FMPV-1 and GM-CSF (as adjuvant) in people with Colorectal Cancer, run by Hubro Therapeutics AS at 1 site in United Kingdom.
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 33 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
Delayed Type Hypersensitivity Skin Reactivity Test (time frame: 45 days). The study lists 3 primary outcomes in all. 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 NCT05238558, which also lists 1 linked publication.
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 21 Sep 2023.