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Head and Neck CancerPhase 2NCT05608876

A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer

A Phase 2 study testing Tigilanol Tiglate in people with Head and Neck Cancer, run by QBiotics Group Limited at 7 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Phase II, open label, single arm study to assess the efficacy of intratumoural tigilanol tiglate in various head and neck solid malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Tigilanol Tiglate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
7 sitesin 2 countries
Study dates
3 Nov 2022to Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are willing and able to provide written informed consent for the study prior to any protocol-specific procedures and to comply with all local and study requirements.
  • Are ≥ 18 years of age on the day of providing informed consent.
  • Have a histologically confirmed diagnosis of a solid head and neck malignancy and have either recurrent disease and/or metastatic disease, or have failed on at least one line of systemic therapy. Tumour types can include: HNSCC, sino-nasal cancers, salivary gland cancers, and peri-stomal laryngeal carcinomas with pre-existing tracheostomy.
  • Have disease that is amenable to intratumoural injection either by palpation or under ultrasound guided injection. Lymph nodes with metastatic disease from the patient's head and neck cancer can be selected for treatment. Note: Measurable disease as per RECIST v1.1. is not mandatory.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  • Have life expectancy of more than 12 weeks.
  • Female participants who are Women of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test at Screening (within 14 days of the first study drug administration), must be willing to use a highly effective contraception from date of consent, throughout the study period and up to 30 days after the last study drug administration, and must not be breastfeeding.
  • Male participants with a potentially fertile female partner are eligible if they have had a vasectomy or are willing to use adequate contraception from prior to commencement of study drug administration, throughout the study period and up to 30 days after the last study drug administration, and must not donate sperm throughout the study period and up to 30 days after the last study drug administration.

Who cannot join

  • Are planning to receive intratumoural treatment or radiotherapy to any of the tumours intended for injection within 28 days prior to Screening, or during treatment with tigilanol tiglate.
  • Have a tumour intended for injection that is immediately adjacent to, or with infiltration into, any major artery or vein (e.g., if the tumour for injection is located adjacent to the jugular vein).
  • Have a tumour intended for injection located in an area where post-injection swelling could compromise the airway.
  • Have a tumour intended for injection that is a nasal tumour extending into the Ethmoid sinus.
  • Have had any previous intervention (extensive surgery or radiation therapy) in the area of a tumour intended for injection that is in proximity of the airway (such that tracking of the injected fluid may be unpredictable and could lead to airway swelling). Patients with a permanent tracheostomy can be included.
  • Are receiving or have received other investigational agents or have used an investigational device without undergoing a 28-day (or 5 half-lives, whichever is shorter) wash-out period prior to their first treatment with tigilanol tiglate. These patients must have recovered from all AEs due to previous investigational therapies to ≤ Grade 1 at baseline.
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  • Are receiving or have received systemic anticancer therapy, or therapeutic radiation treatment, without undergoing a 28-day (or 5 half-lives, whichever is shorter) wash-out period prior to their first treatment with tigilanol tiglate. These patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 at baseline.
  • Have had major surgery within 28 days of their first treatment with tigilanol tiglate or anticipate the need for major surgery during the study period. Minor surgical procedures are permitted, but with sufficient time for wound healing.
  • Have known, current or history of active cerebral metastasis and/or carcinomatous meningitis.
  • Have any bleeding diathesis or coagulopathy that would make intratumoural injection or biopsy unsafe, or if they are on therapeutic warfarin therapy.
  • Have a history of allergic reactions or severe hypersensitivity (Grade ≥ 3) attributed to tigilanol tiglate or compounds of similar chemical or biologic composition to tigilanol tiglate, any of its excipients or other agents used in the study.
  • In the opinion of the treating Investigator, the patient is not an appropriate candidate for the study for any reason (e.g., they have a known psychiatric or substance abuse disorder that would interfere with their ability to cooperate with the requirements of the study).

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United Kingdom5 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, CH63 4JY

  • Cardiff and Vale University Health Board - University Hospital of Wales (UHW)

    Cardiff, Cardiff, CF14 4XW

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Guy's and St Thomas' NHS Foundation Trust

    London

  • East and North Hertfordshire NHS Trust (Incorporating Mount Vernon Cancer Centre) of Lister Hospital

    Stevenage, Hertfordshire, SH1 4AB

Other trials in United Kingdom

Australia2 sites

  • Metro South Hospital and Health Service, via the Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • The Kinghorn Cancer Centre

    Sydney, New South Wales, 2010

Other trials in Australia

About this study

Official title: A Phase II, Open Label, Single Arm Study To Assess The Efficacy Of Intratumoral Tigilanol Tiglate In Various Head And Neck Solid Malignancies

A Phase II, open label, single arm study to assess the efficacy of intratumoural tigilanol tiglate in various head and neck solid malignancies.

Read the detailed description

Primary Objective

  1. To evaluate tumour ablation following treatment(s) with intratumoural injections of tigilanol tiglate.

Secondary Objectives

  1. To assess the safety and tolerability of intratumoural injections with tigilanol tiglate.
  2. To evaluate disease control by assessing time to local disease recurrence from last treatment.
  3. To evaluate the tumour recurrence rate at injected tumour sites.
  4. To evaluate survival by assessing Progression Free Survival (PFS).

Exploratory Objectives

  1. To assess the impact on Quality of Life (QoL).
  2. To assess the degree of wound healing after each treatment.
  3. To assess the tumour response in injected and non-injected tumours, based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
  4. To assess the tumour response according to intratumoural Response Evaluation Criteria in Solid Tumours (itRECIST).
  5. To assess changes in tumour biomarkers.
  6. To assess the tumour microenvironment.
Being tested
Tigilanol Tiglate
Keywords
Squamous cell carcinomas, Sino-nasal cancers, Salivary gland cancers, Peri-stomal laryngeal carcinomas
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell, Salivary Gland Neoplasms

What participants receive

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

  • Tigilanol TiglateDrug

    Also called EBC-46

    Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.

Study groups in NCT05608876
Study groupRoleWhat they receive
Single Arm, Open LabelExperimentalSingle or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area [BSA]) per treatment.
Receives: Drug: Tigilanol Tiglate

What is being measured

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

  1. Tumour Response

    Proportion of participants who have achieved partial or complete ablation of treated tumour(s) and/or tumour segment(s) following injection(s) with tigilanol tiglate.

    Measured: 72 weeks

Secondary outcomes (4)

  1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Total number of Adverse Events (AEs) and Serious Adverse Events (SAEs) and number of AEs and SAEs deemed related to tigilanol tiglate.

    Measured: 72 weeks

  2. Disease Control

    Time from last treatment to recurrence of disease at injection site(s).

    Measured: 72 weeks

  3. Local Recurrence Rate at injection site(s)

    Percentage of participants with local recurrence at injection site(s) at 6-,12- and 18-months after first treatment.

    Measured: 6-, 12-, and 18-months after first treatment.

  4. Progression Free Survival (PFS)

    Progression Free Survival (PFS) based on RECIST v1.1 defined as the length of time between first treatment and the date of the first occurrence of disease progression.

    Measured: 72 weeks

Timeline

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

  1. First posted8 Nov 2022
  2. Study start3 Nov 2022
  3. Primary completion31 Jul 2025
  4. Study completionAug 2026 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, single arm
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05608876
Sponsor's protocol ID
QB46C-H08
Other IDs
U1111-1282-3152
Status last verified
Aug 2025
First submitted
16 Oct 2022
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tigilanol Tiglate in people with Head and Neck Cancer, run by QBiotics Group Limited at 7 sites in 2 countries.

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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United Kingdom, Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Tumour Response (time frame: 72 weeks). 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 NCT05608876.

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 7 Aug 2025.

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