Trial Title:
A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer
NCT ID:
NCT05608876
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
Squamous cell carcinomas
Sino-nasal cancers
Salivary gland cancers
Peri-stomal laryngeal carcinomas
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Open label, single arm
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tigilanol Tiglate
Description:
Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for
intratumoural treatment of a wide range of solid tumours.
Arm group label:
Single Arm, Open Label
Other name:
EBC-46
Summary:
A Phase II, open label, single arm study to assess the efficacy of intratumoural
tigilanol tiglate in various head and neck solid malignancies.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Are ≥ 18 years of age on the day of providing informed consent.
3. 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.
4. 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.
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
6. Have life expectancy of more than 12 weeks.
7. 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.
8. 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.
Exclusion Criteria:
1. 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.
2. 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).
3. Have a tumour intended for injection located in an area where post-injection
swelling could compromise the airway.
4. Have a tumour intended for injection that is a nasal tumour extending into the
Ethmoid sinus.
5. 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.
6. 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.
7. 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.
8. 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.
9. Have known, current or history of active cerebral metastasis and/or carcinomatous
meningitis.
10. Have any bleeding diathesis or coagulopathy that would make intratumoural injection
or biopsy unsafe, or if they are on therapeutic warfarin therapy.
11. 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.
12. 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Kinghorn Cancer Centre
Address:
City:
Sydney
Zip:
2010
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Robert Kent
Investigator:
Last name:
Richard Gallagher, MBBS
Email:
Principal Investigator
Facility:
Name:
Metro South Hospital and Health Service, via the Princess Alexandra Hospital
Address:
City:
Brisbane
Zip:
4102
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Benedict Panizza, MBBS MBA
Investigator:
Last name:
Benedict Panizza, MBBS MBA
Email:
Principal Investigator
Facility:
Name:
East and North Hertfordshire NHS Trust (Incorporating Mount Vernon Cancer Centre) of Lister Hospital
Address:
City:
Stevenage
Zip:
SH1 4AB
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
George Mochloulis, MD CCST
Investigator:
Last name:
George Mochloulis, MD CCST
Email:
Principal Investigator
Facility:
Name:
The Clatterbridge Cancer Centre NHS Foundation Trust
Address:
City:
Bebington
Zip:
CH63 4JY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Keeley De Costa
Contact backup:
Last name:
Peter Pulman
Investigator:
Last name:
Joseph Sacco, MB ChB
Email:
Principal Investigator
Facility:
Name:
Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
Address:
City:
Cardiff
Zip:
CF14 4XW
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Sara Turley
Investigator:
Last name:
David Owens, MBchB
Email:
Principal Investigator
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Kevin Harrington, BSc MBBS
Investigator:
Last name:
Kevin Harrington, BSc MBBS
Email:
Principal Investigator
Facility:
Name:
Guy's and St Thomas' NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Anthony Kong, MBBS
Investigator:
Last name:
Anthony Kong, MBBS
Email:
Principal Investigator
Start date:
November 3, 2022
Completion date:
October 2026
Lead sponsor:
Agency:
QBiotics Group Limited
Agency class:
Industry
Source:
QBiotics Group Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05608876
