RecruitingPHASE1, PHASE2INTERVENTIONAL

HTL0039732 in Participants With Advanced Solid Tumours

This study is investigating a new medication called HTL0039732 for people with advanced solid tumours, which are cancers that have grown or spread. The researchers want to see how safe and effective this new drug is when given on its own, and when combined with an existing cancer medicine called atezolizumab. HTL0039732 works by blocking a signal that can stop the body's immune system from attacking cancer cells. By blocking this signal, the hope is that the immune system can become more active against the tumour. Atezolizumab is another type of medicine that helps the immune system fight cancer. This study is in its early stages (Phase 1), meaning it's the first time this drug is being tested in humans, primarily to find the safest dose.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Cancer Research UK

Enrolment target

150

Start

13 Jul 2023

Estimated completion

01 Jun 2027

Neoplasms Prostatic Neoplasms, Castration-Resistant Stomach Neoplasms Esophageal Neoplasms Head and Neck Neoplasms Colorectal Neoplasms Pancreatic Neoplasms Lung Neoplasms Urinary Bladder Neoplasms Mesothelioma, Malignant Uterine Cervical Neoplasms Kidney Neoplasms Sarcoma Pheochromocytomas

What is this study about?

This study is looking into a new medication called HTL0039732, designed to help your body's immune system fight advanced solid tumours. Solid tumours are growths of abnormal cells in organs like the stomach, lungs, or prostate. The new drug, HTL0039732, aims to block a specific signal in the body that can stop your immune system from recognising and attacking cancer cells. Think of it like unlocking a brake that the cancer has put on your immune system.

Researchers believe that by removing this 'brake', your immune system might be better able to get rid of the cancer cells. This new drug will be tested in two ways: first, on its own (doctors call this 'monotherapy'), and then in combination with an approved cancer medicine called atezolizumab. Atezolizumab is already used to treat several types of cancer and also works by boosting the immune system's attack on cancer cells. The hope is that combining these two medicines might be even more effective than either one alone.

This study is happening in two main stages, called Phase 1 and Phase 2. Phase 1 is the very first stage where a new drug is given to people. The main goal here is to find the safest and most effective dose of HTL0039732. They will start by giving small doses and gradually increase them to see how people react. Once a safe dose is found, Phase 2 will focus more on how well the treatment works against different types of advanced solid tumours, especially those where this specific immune-blocking signal is thought to be more active.

Key takeaways

This study is testing a new drug, HTL0039732, for advanced solid tumours.
It aims to boost your immune system to fight cancer.
The drug will be given alone and with an existing cancer medicine, atezolizumab.
This is an early-stage study (Phase 1) to find a safe and effective dose.
Participation includes regular check-ups, blood tests, and scans.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or older.

Initially, for the first part of the study (Phase 1, Part A), you would need to have an advanced solid tumour that hasn't responded to standard treatments, or for which there are no other suitable treatments available. Doctors would also need to be able to measure your tumour's size. You would also need to agree to provide tissue samples from your tumour, either from already existing samples or by having a new biopsy (a small tissue removal) if needed.

Later parts of the study (Phase 1, Part B and Phase 2a) will focus on specific types of advanced solid tumours where the particular immune-blocking signal targeted by the drug is thought to be more active. These include cancers like certain bowel cancers, stomach cancer, head and neck cancers, prostate cancer, lung cancer, bladder cancer, and some others, providing further options for participation as the study progresses.

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 an advanced solid tumour?
Has your cancer not responded to usual treatments, or are there no other treatments available?
Are you able to provide tissue samples (biopsy) if needed?
Are you able to attend regular clinic visits and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either HTL0039732 capsules on their own, or HTL0039732 capsules combined with atezolizumab given as a drip (infusion). The study begins with finding the right dose of HTL0039732. This means that groups of participants will gradually receive increasing doses until the safest dose is found. You will have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and the tumour's response. The total duration of your participation will depend on how you respond to the treatment and the stage of the study you are in, but it will involve ongoing assessments and follow-up to track your progress.

Potential risks and benefits

There's a chance this new treatment, HTL0039732, could help control or shrink your cancer, especially by boosting your immune system's ability to fight it. However, because this is an early-stage study, the full benefits are not yet known. Like all medicines, HTL0039732 and atezolizumab can have side effects, which could range from mild to serious. The study team will carefully monitor you for any side effects and provide appropriate care. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (5)

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

Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting
Velindre Cancer Centre
Verified postcode
Cardiff, United Kingdom· Recruiting
Clatterbridge Cancer Centre
Verified postcode
Liverpool, United Kingdom· Recruiting
Guy's Hospital
Verified postcode
London, United Kingdom· Recruiting
The Christie Hospital
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What does 'advanced solid tumours' mean?

This refers to cancers that have grown or spread from where they first started, involving organs like the stomach, lungs, or prostate, rather than blood cancers.

What is HTL0039732?

It's a new experimental drug in capsule form that tries to unblock your immune system so it can fight cancer more effectively.

What is atezolizumab?

Atezolizumab is an existing approved cancer medicine that also helps your immune system fight cancer. In this study, it's given as a drip.

What is a 'Phase 1' study?

It's the first time a new drug is tested in people. The main aim is to find a safe dose and see how the body handles the medicine.

Will this drug cure my cancer?

This is an early-stage study, so we don't know the full effects yet. The goal is to see if it can help control or shrink your cancer, not necessarily to cure it.

How to find out more

Bristi Basu, Dr

bristi.basu@nhs.net +44 (0) 1223 769310 Official trial record

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