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

PHASE2RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Exclusion criteria

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).

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-11-03

Primary completion: 2025-08-01

Study completion finish: 2026-10-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05608876

Intervention or treatment

DRUG: Tigilanol Tiglate

Conditions

• Head and Neck Cancer

Condition: Head and Neck Cancer
DRUG: Tigilanol Tiglate
Sydney, New South Wales, Australia and more
Sponsor: QBiotics Group Limited

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

The Kinghorn Cancer Centre

Research sites nearby

Select from list below to view details:

The Kinghorn Cancer Centre
Sydney, New South Wales, Australia
Metro South Hospital and Health Service, via the Princess Alexandra Hospital
Brisbane, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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.	DRUG: Tigilanol Tiglate Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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 outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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.	72 weeks
Disease Control	Time from last treatment to recurrence of disease at injection site(s).	72 weeks
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.	6-, 12-, and 18-months after first treatment.
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.	72 weeks

Frequently Asked Questions

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References

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