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Healthy VolunteerPhase 1NCT02947854

Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation of Antigen/Adjuvant

A Phase 1 study testing Fimaporfin (Photosensitizer), Hiltonol (Poly-ICLC) and HPV E7 (Human Papilloma Virus E7) peptides in people with Healthy Volunteer, run by PCI Biotech AS at 1 site in United Kingdom.

Completed

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

Official record
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Trial summary

Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance the effects of other drugs in a site-specific, light-directed manner and is used to re-localise endocytosed molecules from endosomes to… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Fimaporfin (Photosensitizer), Hiltonol (Poly-ICLC) and HPV E7 (Human Papilloma Virus E7) peptides
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2016to 26 Mar 2018
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects will be; 1.1. males or females 1.2. Caucasian 1.3. between 18 and 55 years of age, inclusive
  • Subjects will have a 2.1. body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive 2.2. body weight between 50 and 100 kg, inclusive
  • Subjects will be in good health, as determined by; 3.1. medical history, 3.2. physical examination, 3.3. vital signs assessment, 3.4. 12-lead electrocardiogram (ECG) 3.5. clinical laboratory evaluations (congenital non-haemolytic hyperbilirubinaemia is acceptable)
  • Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.

Who cannot join

  • Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception (ie, a condom with spermicidal foam/gel/film/cream/suppository) or to refrain from donating sperm from the time of the first dose until 3 months after the final dose administration.
  • 1.1. Male subjects whose partners of childbearing potential do not agree to use an additional acceptable method of contraception.
  • Female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception from the time of screening until 3 months after the final dose administration.
  • Subjects who have a negative result for the test for human leukocyte antigen (HLA)-A2 (Parts B and C only).
  • Subjects who have donated; 4.1. blood in the 3 months prior to screening, 4.2. plasma in the 7 days prior to screening, 4.3. platelets in the 6 weeks prior to screening.
  • Subjects who; 5.1. consume more than 28 units of alcohol per week if male 5.2. consume more than 21 units of alcohol per week if female 5.3. have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator Note: 1 unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine or 25 mL of spirits
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  • Subjects who smoke more than 10 cigarettes or use the equivalent in tobacco per day.
  • Subjects who have used the following within 7 days of first dose (use of intermittent paracetamol ≤2 g/day is acceptable), unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety:
  • 7.1. any non-prescribed systemic or topical medication 7.2. any herbal remedy 7.3. any vitamin supplement 7.4. any mineral supplement
  • Subjects who have received; 8.1. any prescribed systemic or topical medication (including steroids) within 14 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
  • 8.2. slow-release medicinal formulations considered to still be active within 14 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
  • Subjects who have received a vaccine within 3 months of first dose administration.
  • Subjects who have an abnormality in heart rate, blood pressure, temperature, or respiration rate at screening and prior to first dose that in the opinion of the Investigator increases the risk of participating in the study.
  • Subjects who have; 11.1. a positive urine drugs of abuse screen (confirmed by repeat) at screening or first admission.
  • 11.2. a positive alcohol breath test (confirmed by repeat) at screening or first admission.
  • Subjects who have an abnormality in the 12-lead ECG at screening and prior to first dose that in the opinion of the Investigator increases the risk of participating in the study.
  • Subjects who are pregnant, breastfeeding, or lactating.
  • Subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to first dose administration.
  • Subjects who have previously been exposed to KLH antigen (Parts B and C only).
  • Subjects who have a known previous exposure to HVP E7 (Parts B and C only).
  • Subjects who have a significant history of drug allergy, as determined by the Investigator.
  • Subjects who have a known allergy or sensitivity to Hiltonol and/or photosensitisers.
  • Subjects who have any clinically significant abnormal physical examination finding, as determined by the Investigator.
  • Subjects who have any clinically significant medical history, as determined by the Investigator.
  • Subjects who have any clinically significant allergic condition (excluding non-active hayfever), as determined by the Investigator.
  • Subjects with porphyria or hypersensitivity to porphyrins.
  • Subjects who have, or who have a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, immunological or other major disorder, as determined by the Investigator.
  • Subjects who have had a clinically significant illness within 4 weeks of first dose, as determined by the Investigator.
  • Subjects who have any clinically significant abnormal laboratory safety findings at screening and prior to first dose, as determined by the Investigator (1 repeat assessment is acceptable at each timepoint).
  • Subjects who have a C-reactive protein value that is above the upper limit of normal at screening and prior to first dose (1 repeat assessment is acceptable at each timepoint).
  • Subjects who; 27.1. have serum hepatitis, 27.2. are carriers of the hepatitis B surface antigen (HBsAg), 27.3. are carriers of the hepatitis C antibody, 27.4. have a positive result for the test for human immunodeficiency virus (HIV) antibodies.
  • Subjects who have tattoos, scars, or moles that in the opinion of the Investigator are likely to interfere with dosing or study assessments at any of the potential dosing sites (upper arms or abdomen).
  • Subjects who have previously taken part in or withdrawn from this study.
  • Subjects who, in the opinion of the Investigator, should not participate in this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Covance Clinical Research Unit Limited

    Leeds, LS29LH

Other trials in United Kingdom

About this study

Official title: An Open-label, Phase I/Proof of Principle, Dose Escalation Study to Assess Safety, Tolerability and Immune Response of Fimaporfin-induced Photochemical Internalisation (PCI) of Antigen/Adjuvant in Healthy Male/Female Subjects

Fimaporfin (TPCS2a) is a photosensitiser drug being developed by PCI Biotech AS for use in novel Photochemical Internalisation (PCI) technology. PCI technology is designed to enhance the effects of other drugs in a site-specific, light-directed manner and is used to re-localise endocytosed molecules from endosomes to cytosol. This research study is evaluating the use of the PCI Technology in combination with adjuvant and vaccine antigens for safety and induction of immune responses.

Being tested
Fimaporfin (Photosensitizer), Hiltonol (Poly-ICLC), HPV E7 (Human Papilloma Virus E7) peptides, KLH (Keyhole Limpet Hemocyanin)
Keywords
Vaccine, Photochemical Internalisation, Immune Response, Peptide vaccine, Anti cancer vaccine

What participants receive

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

  • Fimaporfin (Photosensitizer)Drug

  • Hiltonol (Poly-ICLC)Biological

  • HPV E7 (Human Papilloma Virus E7) peptidesBiological

  • KLH (Keyhole Limpet Hemocyanin)Biological

Study groups in NCT02947854
Study groupRoleWhat they receive
Photosensitizer and adjuvantExperimentalRun-in cohort for selection of fimaporfin starting dose in the main study. Single intradermal dosing of fimaporfin and adjuvant (Hiltonol [poly-ICLC]) followed by light application.
Receives: Drug: Fimaporfin (Photosensitizer); Biological: Hiltonol (Poly-ICLC)
Photosensitizer, adjuvant and antigensExperimentalMain part: Intradermal dosing of fimaporfin, adjuvant (Hiltonol, poly-ICLC) and antigens (KLH and HPV E7) followed by light application.
Receives: Drug: Fimaporfin (Photosensitizer); Biological: Hiltonol (Poly-ICLC); Biological: HPV E7 (Human Papilloma Virus E7) peptides; Biological: KLH (Keyhole Limpet Hemocyanin)
Assessments of time between ID dosing and lightExperimentalOptional part: Assessment of different time interval between intradermal dosing of fimaporfin, adjuvant/antigens and light application.
Receives: Drug: Fimaporfin (Photosensitizer); Biological: Hiltonol (Poly-ICLC); Biological: HPV E7 (Human Papilloma Virus E7) peptides; Biological: KLH (Keyhole Limpet Hemocyanin)

What is being measured

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

  1. Incidence of Treatment Emergent Adverse Events

    Safety

    Measured: Up to 1 year

  2. Incidence of abnormal and clinical significant measures

    Clinical Laboratory, ECG, Vital Signs and Physical Examinations

    Measured: Up to 1 year

  3. Pain as measured by Visual Analogue Scale (VAS)

    Tolerability

    Measured: Up to 1 year

  4. Incidence and grading of local skin reactions as by CTCAE v. 4.03

    Local Tolerability (pain, erythema, oedema, induration and ulceration)

    Measured: Up to 1 year

Secondary outcomes (1)

  1. Induction of Immune Response

    Blood samples will be collected prior, during and after treatment for assessment of Antibody Production and T-cell Responses (change from baseline)

    Measured: Up to 1 year

Timeline

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

  1. First posted28 Oct 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion26 Mar 2018
  4. Study completion26 Mar 2018

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02947854
Sponsor's protocol ID
PCIA102-16
Status last verified
Aug 2019
First submitted
12 Oct 2016
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Otterhaug T, Janetzki S, Welters MJP, Hakerud M, Nedberg AG, Edwards VT, Boekestijn S, Loof NM, Selbo PK, Olivecrona H, van der Burg SH, Hogset A. Photochemical Internalization Enhanced Vaccination Is Safe, and Gives Promising Cellular Immune Responses to an HPV Peptide-Based Vaccine in a Phase I Clinical Study in Healthy Volunteers. Front Immunol. 2021 Jan 8;11:576756. doi: 10.3389/fimmu.2020.576756. eCollection 2020.

    PubMed 33488576

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fimaporfin (Photosensitizer), Hiltonol (Poly-ICLC) and HPV E7 (Human Papilloma Virus E7) peptides in people with Healthy Volunteer, run by PCI Biotech 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 4 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 28 Aug 2019. 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?

Incidence of Treatment Emergent Adverse Events (time frame: Up to 1 year). The study lists 4 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 NCT02947854, 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 28 Aug 2019.

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