CompletedPhase IInterventional

An open-label mass balance study of [14C]EIK1001 in healthy male subjects

This study aims to understand how a new investigational cancer medicine, EIK1001, works in the body. Although it's being developed for cancer patients, this particular study needs healthy male volunteers. You would take a single dose of the medicine, which has a tiny amount of radioactivity to help us track it. We want to find out how quickly your body gets rid of the medicine and what it breaks down into. This information is crucial for developing safer and more effective cancer treatments that use the body's own immune system to fight the disease. You'll stay in a clinic for up to 10 nights and have follow-up visits.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Eikon Therapeutics, Inc.

Enrolment target

Start

09 May 2025

Estimated completion

12 Jun 2025

Healthy volunteers

What is this study about?

Researchers are developing a new medicine called EIK1001 to potentially treat cancer. This medicine is designed to work with your body's immune system, helping it to recognise and attack cancer cells more effectively. Current treatments often try to 'unblock' the immune system, but they don't work for everyone, and some people's cancer can still get worse.

EIK1001 aims to boost the immune system's response against tumours, and it could be used alongside existing cancer treatments. The hope is that this type of treatment might even help the immune system 'remember' how to fight the cancer, leading to longer-lasting benefits. While this medicine has already been given to cancer patients, we need to understand how it behaves in healthy people first.

This study will give healthy volunteers a single dose of EIK1001. A tiny amount of 'radiotracers' (which means it's slightly radioactive) will be added to the medicine. This allows us to track it as it moves through your body. We want to find out how quickly your body gets rid of it, what it breaks down into, and whether it causes any important side effects. This information is a vital step in developing this medicine further, with the ultimate goal of offering better options for cancer patients.

Key takeaways

This study helps develop a new cancer treatment.
Healthy men (30-65 years) are needed to participate.
A single dose of study medicine is given by injection.
You'll stay in a clinic for up to 10 nights.
The study involves blood, urine, and stool samples.
You will receive payment for your participation.

Who may be eligible?

This study is looking for healthy men between the ages of 30 and 65 years old. You need to be able to fully understand the study and be willing to take part in all of it. Your overall health will be checked carefully by a doctor, including your medical history, a physical exam, and blood tests, to make sure you are healthy enough for the study.

There are also some specific body measurements required, such as your body mass index (BMI) needing to be between 18 and 35. You'll also need to weigh at least 50 kg and have regular bowel movements. You must also agree to use effective contraception for at least six months after receiving the medicine.

You cannot take part if you have a history of serious allergic reactions to any medicines, or if you have certain health conditions like significant heart, kidney, liver, stomach, or lung diseases. Conditions like diabetes, certain neurological problems, or autoimmune diseases would also prevent you from participating.

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 a man aged between 30 and 65 years?
Do you feel healthy overall and able to follow study instructions?
Do you weigh at least 50 kg?
Do you have a Body Mass Index (BMI) between 18 and 35?
Do you agree to use effective contraception for at least 6 months after the study drug?
Do you have no history of serious allergies to medicines or significant health conditions like heart or kidney disease?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive a single dose of the study medicine, [14C]EIK1001. This medicine will be given as an injection into a vein, usually in your arm. You will then stay at the study clinic for up to 10 nights. After this, you'll have one outpatient visit to the clinic.

Throughout the study, we will collect many blood samples to check how the medicine is processed by your body and to monitor your safety. For at least 9 days, you'll also be asked to collect all your urine and faeces (poo) so that we can measure how much of the medicine and its breakdown products leave your body. The entire study, including follow-up, will take up to 6 weeks to complete. You will also need to follow certain lifestyle rules, like fasting from food and drink (except water) at specific times.

Potential risks and benefits

You won't receive any direct medical benefit from taking part in this study yourself. However, the information we gather is crucial for developing new cancer treatments, which could ultimately help many patients in the future. There's always a chance you might experience side effects from the study medicine, and because it's new, we don't know everything about its effects yet. You'll also be exposed to a tiny amount of radiation, similar to about 35 days of natural background radiation in the UK, which is considered very safe. Our health checks might uncover an important medical issue you weren't aware of. You will be compensated for your time, the inconvenience, and any travel expenses. You are free to withdraw from the study at any time without giving a reason.

Locations (1)

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

Quotient Sciences Limited
City only
Ruddington, Nottingham, United Kingdom

Common questions

What is EIK1001?

EIK1001 is a new medicine being developed to potentially treat cancer by helping your immune system fight the disease.

Why do you need healthy volunteers for a cancer drug study?

We need to understand how the medicine behaves in healthy bodies before we can fully understand its effects in cancer patients.

How will you track the medicine in my body?

The medicine will have a very small amount of radioactivity attached, allowing us to follow its path through your body using special tests.

Will I get paid for taking part?

Yes, you will receive payment for your time, inconvenience, travel, and other expenses related to participating in the study.

What happens if I change my mind during the study?

You are free to leave the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Harry Raftopoulos

raftopoulosh@eikontx.com +1 (0)341777 0139 Official trial record

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