Not yet recruitingPHASE1INTERVENTIONAL

Human ADME Study of [14C]-AZD1390

This study is an early-stage (Phase 1) trial for a new medicine called AZD1390. It's designed for people with advanced solid cancers, excluding blood cancers like lymphoma. The main purpose is to understand how the body processes AZD1390 – how it gets into the body, where it goes, how it's broken down, and how it's removed. This is important information for developing new treatments. About 8 volunteers will take a single dose of the medicine and stay at the study site for about a week. Their participation will help scientists learn more about AZD1390, which could eventually become a treatment for aggressive cancers like glioblastoma (GBM), where new options are urgently needed.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

30 Jun 2026

Estimated completion

12 Apr 2028

Advanced Solid Malignancies

What is this study about?

This is a very early study, known as a Phase 1 trial, looking at a new medicine called AZD1390. Imagine you're trying a new food – you'd want to know how your body reacts to it, right? In a similar way, this study aims to understand how the body handles AZD1390. Researchers will track how it's absorbed into your system, where it goes, how your body changes it, and eventually how it leaves your body.

This kind of study is crucial because it helps researchers understand the basic workings of a new medicine. It’s not primarily about seeing if the medicine treats your cancer right away, but about gathering vital information that will guide future, larger studies. The information from this study will help ensure that if AZD1390 goes on to be tested for its treatment effects, it’s done safely and effectively. This medicine is being developed with the hope of treating serious cancers where current treatments aren’t always enough, such as a type of brain cancer called glioblastoma (GBM).

Even though the immediate risk is considered low in this early study, your participation is incredibly valuable. You'll be helping to build essential knowledge that could pave the way for new cancer treatments in the future, offering hope to many people facing difficult diagnoses.

Key takeaways

An early-stage study (Phase 1) for a new cancer medicine called AZD1390.
Aims to understand how the body processes the medicine, not to treat your cancer directly.
For adults (18-99) with advanced solid tumours, excluding blood cancers.
Involves a single dose of the medicine and an 8-day stay at a study site.
Your health will be closely monitored by a medical team.
Participation contributes vital knowledge for future cancer treatments, especially for aggressive cancers like glioblastoma.

Who may be eligible?

This study is looking for people aged between 18 and 99 who have advanced solid tumours (cancers that form solid lumps, not blood cancers). To be considered, your cancer should have been clearly identified by a doctor, and you shouldn't be undergoing other cancer treatments at the time of the study.

You also need to be reasonably fit and active for someone with your condition, able to carry out your daily tasks without too much trouble, and expected to live for at least 12 more weeks. Your kidneys, liver, and bone marrow (where blood cells are made) need to be working well, and you should have regular bowel movements without significant weight loss due to your cancer. Specific conditions, like having certain heart problems, poorly controlled diabetes, or other serious health issues, would mean you couldn't take part.

There are also some specific health concerns that would prevent you from joining, such as a history of muscle problems, lung scarring (ILD), severe liver disease, epilepsy, certain blood disorders, or if you've already had another serious cancer. If you have any ongoing side effects from previous cancer treatments that are still significant, or if your cancer has spread to your brain or spinal cord in a way that's causing problems within the last month, you wouldn't be able to participate.

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.

Do I have a solid tumour (not a blood cancer) that is advanced?
Am I generally able to do my daily activities and don't have severe symptoms?
Are my kidneys, liver, and bone marrow (where blood is made) healthy enough?
Do I have regular bowel movements and haven't lost a lot of weight due to my cancer recently?
Have I had any muscle problems, serious lung conditions, or liver disease in the past?
Am I free from certain other serious health issues like epilepsy or certain blood disorders?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a single dose of the study medicine, AZD1390, which will include a very small, safe amount of a special marker (C-14) to help researchers track it. After receiving the dose, you'll need to stay at the study site, usually a hospital, for about 8 days (until Day 8). During this time, the medical team will closely monitor you and take regular samples of blood and urine. These samples will help them understand how your body handles the medicine.

After you leave the study site on Day 8, you'll have some follow-up appointments to make sure you're doing well. The total time you'd be involved in the study, including follow-ups, would be explained to you in detail. Throughout your participation, your health will be regularly checked by the study team.

Potential risks and benefits

Taking part in any medical study carries some potential benefits and risks. For this very early-stage trial, the main benefit isn't necessarily a direct improvement in your cancer, but rather the knowledge gained. Your participation will help scientists learn crucial information about AZD1390, which could lead to new treatments for others in the future. The risks involve potential side effects from the medicine, some of which are unknown at this early stage. The amount of the medicine and the special marker are kept very low to minimise these risks. The study team will explain all known or potential risks to you in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Research Site
Verified postcode
Guildford, United Kingdom
Research Site
Verified postcode
Liverpool, United Kingdom

Common questions

What does 'Phase 1 study' mean?

Phase 1 is the first step in testing a new medicine in people. It mainly checks how safe the medicine is and how the body handles it, rather than if it treats the disease.

What kind of cancer is this study for?

This study is for people with advanced 'solid tumours' – cancers that form a lump, rather than blood cancers. It's not limited to one specific type of solid cancer.

What will I actually have to do in this study?

You'll take one dose of the study medicine and then stay at the study site (like a hospital) for about 8 days. During this time, doctors will give you health checks and take blood and urine samples.

Will this medicine cure my cancer?

This study is not designed to cure cancer. It's an early step to understand how a new medicine works in the body. While it won't directly treat your cancer, it helps researchers develop future treatments.

Can I leave the study if I change my mind?

Yes, absolutely. You can decide to leave the study at any time, for any reason. It won't affect your regular medical care or relationship with your doctors.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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