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

NCT05608876 | Active Not Recruiting Phase 2

• 2 other identifiers: QB46C-H08U1111-1282-3152
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Conditions

Head and Neck Cancer

Keywords

Squamous cell carcinomas; Sino-nasal cancers; Salivary gland cancers; Peri-stomal laryngeal carcinomas

Outcome Measures

Primary Outcomes (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.

  72 weeks

Secondary Outcomes (4)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  72 weeks

• Disease Control

  72 weeks

• Local Recurrence Rate at injection site(s)

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

• Progression Free Survival (PFS)

  72 weeks

Other Outcomes (8)

• General Cancer Quality of Life (QoL) Assessment

  72 weeks

• Head and Neck Cancer Quality of Life (QoL) Assessment

  72 weeks

• Wound Healing

  72 weeks

Study Arms (1)

Single Arm, Open Label

EXPERIMENTAL

Single or multiple Intratumoural injections of tigilanol tiglate at up to a fixed dose of 3.6 mg/m2 (Body Surface Area \[BSA\]) per treatment.

Drug: Tigilanol Tiglate

Interventions

Tigilanol Tiglate DRUG

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

Also known as: EBC-46

Single Arm, Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• QBiotics Group Limited: lead

Study Sites (7)

The Kinghorn Cancer Centre

Sydney, New South Wales, 2010, Australia

Location

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

Brisbane, Queensland, 4102, Australia

Location

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

Cardiff, Cardiff, CF14 4XW, United Kingdom

Location

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

Stevenage, Hertfordshire, SH1 4AB, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Bebington, Wirral, CH63 4JY, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Salivary Gland Neoplasms

Interventions

EBC-46

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Study Officials

• Richard Gallagher, MBBS

  The Kinghorn Cancer Centre

  PRINCIPAL INVESTIGATOR

• David Owens, MBchB

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

  PRINCIPAL INVESTIGATOR

• Anthony Kong, MBBS

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Joseph Sacco, MBchB

  The Clatterbridge Cancer Centre NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Benedict Panizza, MBBS MBA

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

  PRINCIPAL INVESTIGATOR

• Kevin Harrington, BSc MBBS

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• George Mochloulis, MD CCST

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, single arm

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: November 8, 2022
• Study Start: November 3, 2022
• Primary Completion: July 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5); AU (2)