RecruitingPHASE1, PHASE2INTERVENTIONAL

EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial - 1)

This study, called EMITT-1, is looking into a new treatment, GRWD5769, for people with advanced solid cancers. It works by targeting a part of your body that helps your immune system recognise and fight cancer cells. Sometimes, the immune system gets tired, but GRWD5769 aims to 'wake it up' to fight the cancer again. The study will test GRWD5769 on its own and also in combination with another approved anti-cancer drug called cemiplimab (Libtayo®). This is a 'first-in-human' study, meaning it's one of the first times this drug is being tested in people, so researchers will be carefully checking if it's safe and helpful.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Grey Wolf Therapeutics

Enrolment target

300

Start

21 May 2023

Estimated completion

30 Apr 2028

Advanced Solid Malignancy

What is this study about?

The EMITT-1 study is exploring a new treatment called GRWD5769 for people who have advanced solid cancers. These are cancers that have spread or are difficult to treat with standard therapies. The main idea behind this new drug is to give your own body's defence system – your immune system – a boost to fight the cancer more effectively.

Inside your body, there's a natural process that helps your immune system spot cancer cells. However, in people with cancer, this recognition system can sometimes stop working well, and the immune cells that should be fighting the cancer become 'tired'. GRWD5769 works by blocking a specific enzyme, called ERAP1. By blocking this enzyme, the drug aims to make the cancer cells look different to your immune system, essentially flagging them as a target again so your immune system can restart its attack.

Researchers leading this study hope that GRWD5769, either by itself or when given alongside another anti-cancer drug like cemiplimab (Libtayo®), could significantly improve how well your immune system fights the cancer. This could lead to better outcomes for people with advanced cancers where current treatments might not be enough.

Key takeaways

This study is testing a new drug, GRWD5769, for advanced solid cancers.
GRWD5769 aims to boost your immune system's ability to fight cancer.
It will be tested alone and in combination with another cancer drug (Libtayo®).
It's a 'first-in-human' study, carefully checking for safety and effectiveness.
Participation involves regular clinic visits, tests, and taking the study drug.

Who may be eligible?

This study is for adults aged 18 or over who have advanced or spread solid cancers. This means cancers that doctors usually call 'locally advanced' or 'metastatic'. You would be considered if current standard treatments are no longer working, are not available, or if you can't have them or have chosen not to.

To join, you need to be generally well enough to take part in a study, as assessed by the research team. This includes being able to take medications by mouth. You also need to agree to providing some past medical information, such as previous scans or tissue samples if you have them. Your doctors will also need to believe you have at least a 3-month life expectancy to ensure you can participate safely.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and use very effective birth control during the study. If you are a man, you’ll also need to use condoms and ensure your partner uses effective birth control if there’s a chance of pregnancy. This is to make sure the study drug doesn't affect an unborn baby. For certain parts of the study, you may also need to agree to have regular small tissue samples (biopsies) taken from your tumour.

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 cancer that is difficult to treat or has spread?
Are you able to take medications by mouth?
Are you willing to use effective birth control if you could have children?
Are you generally well enough for a clinical study, as assessed by a doctor?

Answer every question to see your result.

What does participation involve?

If you decide to join the EMITT-1 study, you will be part of either Module 1 or Module 2. In Module 1, you will receive the new drug, GRWD5769, on its own. In Module 2, you will receive GRWD5769 along with another anti-cancer drug called Libtayo® (cemiplimab), which is given into your vein.

The study involves regular visits to the clinic for medical check-ups, blood tests, and scans to see how you are responding to the treatment. You will need to take the study drug by mouth and keep a record of when you take it. For some participants, and only if you agree, small tissue samples (biopsies) might be taken from your tumour during the study to help researchers understand how the drug is working. The research team will explain the full schedule of visits, tests, and how long your participation is expected to last, and you will have ongoing follow-up.

Potential risks and benefits

Participating in this study might offer a potential benefit if GRWD5769 helps your immune system fight your cancer more effectively, either alone or with other treatments. However, as GRWD5769 is a new investigational drug, there might be side effects or risks that are currently unknown. The research team will carefully monitor you for any side effects throughout the study and will explain all known potential risks in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (29)

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

GenesisCare Research
Verified postcode
Adelaide, Australia· Withdrawn
Southern Oncology Clinical Research Unit (SOCRU)
Verified postcode
Bedford Park, Australia· Recruiting
Blacktown Hospital
Verified postcode
Blacktown, Australia· Recruiting
Kinghorn Cancer Centre (KCC)
Verified postcode
Darlinghurst, Australia· Recruiting
Austin Health
Verified postcode
Heidelberg, Australia· Recruiting
Alfred Health
Verified postcode
Melbourne, Australia· Recruiting
Mater Research
Verified postcode
South Brisbane, Australia· Recruiting
Cancer Care Wollongong
Verified postcode
Wollongong, Australia· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting
Institut Paoli-Calmettes
Verified postcode
Marseille, France· Recruiting
Centre Eugène Marquis
Verified postcode
Rennes, France· Recruiting
Institut de Cancérologie de l'Ouest (ICO)
Verified postcode
Saint-Herblain, France· Recruiting

Common questions

What type of cancer is this study for?

This study is for people with advanced solid cancers that have spread or are difficult to treat with standard care.

What is GRWD5769?

GRWD5769 is a new experimental drug that aims to help your own immune system recognise and fight cancer cells more effectively.

Will I receive GRWD5769 on its own or with another drug?

Depending on which part of the study you join, you will either receive GRWD5769 by itself, or GRWD5769 combined with another anti-cancer drug, cemiplimab (Libtayo®).

Will I have to have biopsies?

For some parts of the study, you might be asked to agree to have small tissue samples (biopsies) taken from your tumour. The research team will discuss this with you.

How long will I be in the study?

The full duration of your participation, including treatment and follow-up, will be explained in detail by the study team.

How to find out more

Grey Wolf Therapeutics Patient enquiries

enquiries@gwt.bio +44 1235644970 Official trial record

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