Active not recruitingPHASE2INTERVENTIONAL

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

This study, called a Phase II trial, is looking at a new treatment called Tigilanol Tiglate for people with head and neck cancer. The treatment involves injecting the medicine directly into the tumours. The main goal is to see if these injections can effectively get rid of or shrink the tumours. Researchers also want to find out if the treatment is safe and what side effects it might have. They'll be watching to see how long it takes for the cancer to come back, if at all, and how the treatment affects patients' quality of life. This study is for patients whose head and neck cancer has returned, spread, or hasn't responded to other treatments. It's an important step in finding new ways to fight this type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

QBiotics Group Limited

Enrolment target

Start

03 Nov 2022

Estimated completion

01 Aug 2026

Head and Neck Cancer

What is this study about?

This study is a medical research project focused on finding new and better ways to treat head and neck cancer. Head and neck cancers are a group of cancers that start in areas like the mouth, throat, voice box, and sinuses. If you or someone you know has been diagnosed with head and neck cancer, you'll know how challenging it can be.

In this study, doctors are investigating a new medicine called Tigilanol Tiglate. This medicine will be given directly into the tumours themselves, using an injection. The main purpose is to see how well this medication can shrink or completely remove the tumours in people who have head and neck cancer that has come back, spread, or hasn't responded well to previous treatments. Often, these types of cancers can be difficult to treat, so new options are always being explored.

Beyond just seeing if the treatment works, the research team will also be carefully checking for any side effects to make sure the treatment is safe. They'll be looking at how long it takes for the cancer to return after treatment, how it affects your overall health, and your quality of life. By understanding these aspects, doctors hope to learn if Tigilanol Tiglate could be a useful new treatment option in the future.

Key takeaways

This study is testing a new injectable medicine for head and neck cancer.
It's for people whose cancer returned or didn't respond to other treatments.
The main goals are to see if the medicine shrinks tumours and if it's safe.
Participation involves direct tumour injections and regular check-ups.
You have the right to leave the study at any time.
This research might lead to new treatment options for head and neck cancer.

Who may be eligible?

To join this study, you must be at least 18 years old. You need to have been diagnosed with a solid head and neck cancer that has either come back, spread to other parts of your body, or didn't respond to at least one previous treatment. Examples of these cancers include certain throat, sinus, salivary gland, or voice box cancers, especially if you already have a breathing tube (tracheostomy).

The cancer needs to be in a place where a doctor can easily feel it or see it with an ultrasound so they can give the injection directly into the tumour. This can include cancerous lymph nodes in your neck. Your overall health should be reasonably good, meaning you can generally carry out most daily activities without too much difficulty, and doctors expect you to live for more than 12 weeks.

There are also some important rules around pregnancy and contraception. If you are a woman who could become pregnant, you must have a negative pregnancy test and agree to use effective birth control during and for 30 days after the study. Men with female partners who could become pregnant must also use effective birth control or have had a vasectomy, and should not donate sperm during the same period.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have head and neck cancer that has come back, spread, or not responded to previous treatment?
Is your tumour in a place where it can be directly injected?
Are you generally well enough to do most daily activities?
Are you able to use effective contraception if you or your partner could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors will inject the study medicine, Tigilanol Tiglate, directly into your head and neck tumours. You will have regular visits to the clinic so the medical team can carefully check how you're responding to the treatment and monitor any side effects. This will involve physical examinations, potentially some scans, and possibly blood tests to monitor your health and the cancer's progress. They will also ask you questions about how you are feeling and your quality of life. The exact number of visits and the total length of your participation will depend on how you respond to the treatment, but there will be ongoing follow-up to check for recurrence. You will be closely monitored throughout the treatment period and afterwards.

Potential risks and benefits

Participating in a clinical trial like this could potentially offer new treatment options for your head and neck cancer, especially if other treatments haven't worked well for you. You would be among the first to receive this new medicine, which could lead to shrinking of your tumours or better control of your cancer. However, as with any new medicine, there are risks. You might experience side effects from the injections, which could range from mild to serious, and the treatment might not work for you. The medical team will explain all known potential risks in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your standard medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Kinghorn Cancer Centre
Verified postcode
Sydney, Australia
Metro South Hospital and Health Service, via the Princess Alexandra Hospital
Verified postcode
Brisbane, Australia
Cardiff and Vale University Health Board - University Hospital of Wales (UHW)
Verified postcode
Cardiff, United Kingdom
East and North Hertfordshire NHS Trust (Incorporating Mount Vernon Cancer Centre) of Lister Hospital
Verified postcode
Stevenage, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Verified postcode
Bebington, United Kingdom
The Royal Marsden NHS Foundation Trust
Verified postcode
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is Tigilanol Tiglate?

Tigilanol Tiglate is a new medicine being tested in this study. It's designed to be injected directly into cancer tumours to try and destroy them.

What is a Phase II study?

A Phase II study means this medicine has already passed earlier safety tests. Now, doctors want to see if it works well and what its main benefits and side effects are in a larger group of patients.

Will this injection cure my cancer?

This study aims to see if the injection can shrink or remove tumours. While every effort is made, there's no guarantee the treatment will cure your cancer. We are trying to find new and better ways to treat it.

What kind of side effects might I experience?

As an injected medicine, you might have some redness, pain, or swelling at the injection site. The medical team will tell you all the known potential side effects you might experience before you decide to join.

Will I still receive my regular cancer care?

This study treatment is an addition to, or alternative for, standard care, but you will still receive appropriate follow-up and care for your cancer. Participating won't stop you from getting other necessary medical care.