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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05608876




Registration number
NCT05608876
Ethics application status
Date submitted
16/10/2022
Date registered
8/11/2022
Date last updated
17/01/2024

Titles & IDs
Public title
A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer
Scientific title
A Phase II, Open Label, Single Arm Study To Assess The Efficacy Of Intratumoral Tigilanol Tiglate In Various Head And Neck Solid Malignancies
Secondary ID [1] 0 0
U1111-1282-3152
Secondary ID [2] 0 0
QB46C-H08
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tigilanol Tiglate

Experimental: Single Arm, Open Label - 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.


Treatment: Drugs: Tigilanol Tiglate
Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tumour Response
Timepoint [1] 0 0
72 weeks
Secondary outcome [1] 0 0
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
72 weeks
Secondary outcome [2] 0 0
Disease Control
Timepoint [2] 0 0
72 weeks
Secondary outcome [3] 0 0
Local Recurrence Rate at injection site(s)
Timepoint [3] 0 0
6-, 12-, and 18-months after first treatment.
Secondary outcome [4] 0 0
Progression Free Survival (PFS)
Timepoint [4] 0 0
72 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
37
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
The Kinghorn Cancer Centre - Sydney
Recruitment hospital [2] 0 0
Metro South Hospital and Health Service, via the Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Hertfordshire
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Wirral
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Cardiff
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
QBiotics Group Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05608876
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Gallagher, MBBS
Address 0 0
The Kinghorn Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Head of Human Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 738 708 933
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05608876