CompletedPhase IInterventional

Accelerating the development and implementation of DNA damage inhibitor and radiotherapy treatment (with or without immunotherapy) in head and neck squamous cell carcinoma

Head and neck cancer affects around 12,000 people in the UK each year. Radiotherapy is a standard and effective treatment, but researchers want to see if adding a new targeted drug called ceralasertib can make it work even better. Ceralasertib works by blocking the repair systems inside cancer cells, making them more sensitive to radiation. Because this is an early Phase I trial, the main goal is safety. Doctors want to discover the highest dose of the drug that patients can safely take alongside their radiotherapy. Up to 60 participants will receive the study medicine at gradually increasing doses, while a smaller group of up to 20 patients will receive radiotherapy alone so researchers can compare the results. Taking part also includes answering questionnaires about your quality of life, with optional blood and tissue tests to see how the body handles the drug.

At a glance

Status

Completed

Phase

Phase I

Sponsor

University of Birmingham

Enrolment target

Start

01 May 2021

Estimated completion

23 Jan 2026

Primary head and neck squamous cell carcinoma (HNSCC): laryngeal, hypopharyngeal, oropharyngeal cancer

What is this study about?

Head and neck cancer can start in several places, including the mouth, throat, or voice box. At the moment, radiotherapy is one of the main treatments used across the NHS. Radiotherapy uses high-energy beams to damage the genetic material inside cancer cells so they cannot grow. However, some cancer cells manage to repair this damage and survive.

This study, called ADePT-DDR, looks at whether an experimental drug named ceralasertib (also known as AZD6738) can stop cancer cells from fixing themselves. By weakening their repair tools, the drug may help radiotherapy destroy the cancer cells more effectively. Researchers hope this combination will lead to better long-term results for patients in the future.

Because this is a Phase I trial, the primary focus is finding out how safe the combination is. Doctors start with small doses of the drug in the first group of patients. If those patients do well without severe side effects, the next group receives a slightly higher dose. This step-by-step approach helps doctors find the best dose that gives the strongest benefit while keeping side effects manageable.

The trial is taking place at specialised hospital cancer centres across the UK and is managed by the University of Birmingham. The findings will help shape how doctors treat head and neck cancers in years to come.

Key takeaways

Testing a new drug called ceralasertib taken alongside standard radiotherapy.
A Phase I study focused on finding the safest and most effective dose.
Open to UK adults newly diagnosed with head and neck cancer who have not had prior treatment.
Most patients receive the trial tablets, while some receive standard radiotherapy alone for comparison.
Taking part is voluntary, and you can withdraw at any time without losing any NHS support.

Who may be eligible?

This trial is open to adults aged 18 and over who have been newly diagnosed with squamous cell cancer of the head and neck, such as cancer of the throat or voice box. To join, your medical team must have already decided that a full course of radiotherapy is the right next step for you, and you must not have had any previous treatment for this cancer before.

You will also need to be reasonably active and well enough to carry out daily tasks, which doctors measure using a simple fitness score. Because your body needs to process the new medicine safely, your routine blood tests must show that your liver, kidneys, and bone marrow are working at healthy levels.

You will not be able to join if you have already had treatment for head and neck cancer, or if you are pregnant or breastfeeding. Both men and women who could have children must agree to use reliable contraception throughout the study and for at least six months afterwards, as the effects of the study drug on an unborn baby are not yet known.

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.

I am aged 18 or older.
I have been diagnosed with squamous cell cancer of the head or neck (such as the throat, mouth, or voice box).
My care team has recommended radiotherapy as my main treatment.
I have not had any previous cancer treatment for this condition.
I am well enough to walk around and carry out light daily activities.
I am willing to use reliable contraception during and after the trial if applicable.

Answer every question to see your result.

What does participation involve?

If you take part, your treatment will depend on which group you join. Most participants will receive the study drug, ceralasertib, taken as tablets twice a day for up to 20 days alongside their standard radiotherapy course. A smaller group will receive standard radiotherapy on its own so doctors can compare how both groups feel and recover. Radiotherapy is given in daily hospital sessions over several weeks.

You will have regular hospital visits to check your blood, monitor any side effects, and see how your body is coping. You will also be asked to fill in simple questionnaires about your daily life, physical symptoms, and emotional well-being. There are optional blood tests to check how the drug travels through your bloodstream, as well as an option to let researchers study tumour samples you have already had taken. After your treatment ends, your doctor will continue to monitor your health during routine clinic follow-ups.

Potential risks and benefits

Taking part may give you access to a new treatment that could make radiotherapy more effective, but doctors cannot guarantee that you will benefit directly. However, your participation will provide vital information to improve care for future patients. Like all cancer treatments, this combination carries a risk of side effects. You may experience standard radiotherapy effects, such as a sore mouth or fatigue, alongside possible drug effects like mild nausea or changes in your blood cell counts. Your medical team will monitor you closely and treat any problems quickly. Joining the trial is entirely your choice, and you can withdraw at any time without your regular NHS care being affected.

Locations (1)

Queen Elizabeth Hospital
Approximate
Birmingham, England

Common questions

What is a Phase I clinical trial?

A Phase I trial is an early-stage study designed to test a new medicine or combination for the first time in a small group of people. Its main goal is to check safety and find the right dose.

Will I definitely receive the new trial drug?

Not necessarily. Most people in the study will receive the new drug alongside radiotherapy, but up to 20 people will be in a comparison group that receives radiotherapy alone.

Do I have to agree to the extra blood and tissue tests?

No. The tests looking at how the drug moves through your body and the research using past tissue samples are completely optional. You can say no to them and still take part in the main study.

How is the trial medicine taken?

Ceralasertib comes as tablets that you swallow twice a day for a set number of days while you are having your radiotherapy.

What happens if I change my mind during the trial?

You are free to leave the trial at any point, for any reason. If you decide to stop, your doctors will switch you to standard treatment and your normal NHS care will continue as usual.

How to find out more

Jasmin Cheang

adept-ddr@trials.bham.ac.uk +44 (0)121 4149247 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.