RecruitingPHASE1INTERVENTIONAL

Lutathera and ASTX727 in Neuroendocrine Tumours

This study is for people with neuroendocrine tumours. Researchers want to see if taking a medication called ASTX727 for five days before receiving Lutathera treatment can make Lutathera more effective. Lutathera is a standard treatment for these types of tumours, and ASTX727 might help the tumour cells become more receptive to it. Doctors will use special scans during the study to check how the tumour cells react to ASTX727 and Lutathera. The goal is to find out if this new combination could be a better way to treat neuroendocrine tumours, potentially offering more effective options for patients.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Imperial College London

Enrolment target

Start

25 Apr 2022

Estimated completion

28 Feb 2029

Neuroendocrine Tumors

What is this study about?

This study is investigating a new approach for people living with neuroendocrine tumours. Neuroendocrine tumours are a type of cancer that can develop in different parts of the body. For some patients, standard treatments, like Lutathera, might not work as well as hoped, perhaps because the tumour cells don't fully respond to the treatment.

In this study, doctors are exploring whether a medication called ASTX727 can help make tumour cells more sensitive to Lutathera. Imagine the tumour cells have a sort of 'lock' that Lutathera needs to attach to in order to work. Sometimes, this 'lock' isn't as available as it should be. ASTX727 might help bring more of these 'locks' to the surface of the tumour cells, making it easier for Lutathera to do its job. Researchers will use special imaging scans to see if this is happening.

The main aim is to see if giving ASTX727 first can make Lutathera treatment more effective. This is a Phase 1 study, meaning it's one of the first steps in testing a new treatment combination in people. The information gathered will help doctors understand if this new combination could eventually become a better treatment option for neuroendocrine tumours, offering new hope for patients.

Key takeaways

This study explores a new combination treatment for neuroendocrine tumours.
It aims to make standard Lutathera treatment more effective by adding a new drug, ASTX727.
You would take ASTX727 pills for 5 days, then receive Lutathera treatment.
The study involves regular visits, scans, and follow-up for about eight months of active treatment.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of a neuroendocrine tumour. Your tumour must have progressed or you haven't tolerated your first treatment, such as somatostatin analogues. Doctors will also check that you are generally well enough to take part and your body is functioning adequately.

Important specific requirements include that your tumour cells shouldn't currently show strong uptake on a special scan called a [68Ga]-DOTA-TATE PET scan. Also, your tumour needs to be measurable, and if you're a woman who could become pregnant or a sexually active man, you'll need to use effective contraception during the study and for six months afterwards.

However, you cannot join if you've already had either of the study medications (ASTX727 or Lutathera) before, or if you have certain serious medical conditions, a history of organ transplant, or HIV. The study team will review your full medical history to make sure the study is a safe and suitable option for you.

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 a confirmed diagnosis of a neuroendocrine tumour that has progressed or you can't tolerate your current treatment?
Do your tumour cells not show strong uptake on a special [68Ga]-DOTA-TATE PET scan or less than background liver uptake?
Have you not previously received either Lutathera or ASTX727?
Are you able and willing to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive ASTX727 tablets by mouth for five days. Then, three days later, you will have your Lutathera treatment. This cycle will repeat every two months, for a total of four cycles, unless your condition worsens, the treatment isn't tolerated, or you choose to stop.

Throughout the study, you'll have regular medical check-ups and scans to see how you're responding to the treatment. These scans will include the special [68Ga]-DOTA-TATE PET scans as well as other standard imaging. After two cycles of Lutathera, and again at the end of all cycles, doctors will re-evaluate your tumour.

After your treatment cycles are complete, you'll continue to have follow-up visits every three months to monitor your health and the status of your disease. The total duration of your active treatment will be about eight months, followed by continued monitoring until your disease progresses, you withdraw, or sadly, you pass away.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. While there's no guarantee, a potential benefit of this study could be that the combination of ASTX727 and Lutathera might work better than Lutathera alone, possibly making your treatment more effective. However, like all medications, ASTX727 and Lutathera can cause side effects. The study team will carefully monitor you for any side effects and will explain all known risks before you decide to participate. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

Hammersmith Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What are neuroendocrine tumours?

Neuroendocrine tumours (NETs) are a type of cancer that starts in cells that are like nerve cells and hormone-producing cells. They can grow slowly or quickly and appear in various parts of the body.

What is Lutathera?

Lutathera is a targeted radiotherapy treatment used for certain types of neuroendocrine tumours. It works by delivering radiation directly to cancer cells that have a specific 'receptor' on their surface.

What is ASTX727?

ASTX727 is a study medication being investigated. In this trial, it's being given before Lutathera to see if it can help tumour cells respond better to Lutathera.

What is a Phase 1 study?

A Phase 1 study is an early stage of clinical research. Its main goal is to check the safety of a new treatment or treatment combination and to find the best dose, rather than to confirm how well it works.

Will I have to pay to be in the study?

No, you will not have to pay for the study medications or treatments provided as part of the trial.

How to find out more

Rohini Sharma, Professor

rohini.sharma2@nhs.net 02083833170 Official trial record

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