RecruitingPHASE1INTERVENTIONAL

AZD5305 hADME in Patients With Advanced Solid Malignancies

This study is testing a new drug called Saruparib in people with advanced solid cancers. It’s a Phase 1 study, which means it’s one of the first times this drug is being tested in humans to understand how it works. Researchers want to see how much of the drug the body absorbs, how it spreads, how it’s broken down, and how it leaves the body. They will use a special, tiny dose of the drug with a tracer, along with the regular drug dose. This will help them understand its journey through your system when taken by mouth and given through a vein.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

02 Apr 2025

Estimated completion

02 Oct 2026

Locally Advanced or Metastatic Solid Tumor

What is this study about?

This study, called AZD5305 hADME, is being done for people who have advanced solid cancers that are either locally advanced (meaning they've spread a bit in the local area) or have spread to other parts of the body (metastatic). The main goal is to understand a new drug called Saruparib. Think of it like this: when you take a medicine, your body does many things with it – it absorbs it, moves it around, breaks it down, and finally gets rid of it. This process is called ADME (Absorption, Distribution, Metabolism, Excretion).

The researchers want to know exactly how Saruparib goes through this journey. They're particularly interested in how well the body absorbs it when taken by mouth and how it behaves once it's inside. This information is really important because it helps doctors figure out the best way to give the drug and the right dose for future patients. It’s a crucial step in developing new treatments.

To do this, a tiny amount of the drug will have a special 'tag' (a radiotracer) so scientists can track its path very precisely. This is a common and safe method used in drug development to gather detailed information that can't be found in other ways. By understanding how Saruparib moves through the body, researchers can make better decisions about how to use it safely and effectively for cancer patients in the future.

Key takeaways

This study is for people with advanced solid cancers.
It's about understanding how a new drug, Saruparib, works in the body.
You will stay in hospital for parts of the study.
Samples of blood, urine, and stool will be collected.
It's a crucial step in developing new cancer treatments.
You can stop participating at any time.

Who may be eligible?

This study is looking for both men and women aged 18 or over. You would need to have an advanced solid cancer that has either spread locally or to other parts of your body, and where standard treatments haven't worked or can't be used. You must be generally well enough to take part, meaning you can look after yourself and have healthy body functions (like your organs and blood cells) as checked by the study doctors. You should also be willing and able to stay in hospital for specific periods during the study.

There are certain reasons why someone might not be able to join. For example, if you have a history of certain blood disorders like MDS/AML, or if you have severe ongoing bleeding issues. Also, if you have severe nausea and sickness, serious bowel problems, or have had major bowel surgery that might stop the drug from being properly absorbed, this study might not be right for you. People with other active cancers or ongoing serious side effects from previous cancer treatments that haven't cleared up (apart from hair loss) would also not be able to join.

Quick self-check

Are you 18 years or older?
Do you have advanced solid cancer where standard treatments haven't worked?
Are you generally well and able to care for yourself?
Can you stay in hospital for specific periods?
Do you have regular bowel movements?
Do you not have a history of certain specific blood disorders or severe bleeding issues?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it will involve two main parts. You will be admitted to the hospital, usually for several days at a time, for each part. Before you start, there will be a screening period of up to 28 days to check if you're suitable. In the first part, you'll receive Saruparib by mouth and also a tiny, specially tracked dose through a vein. In the second part, you'll receive the tracked Saruparib by mouth.

During your hospital stays, nurses and doctors will collect samples of your blood, urine, and stool (and vomit if it occurs) to see how the medicine travels through your body and how it leaves. This helps them track the drug very accurately. You will also have regular checks to make sure you are safe. After you leave the hospital for each part, there will be a follow-up visit to check on you. Once both parts are complete and you've had your follow-up, your doctor might be able to continue giving you Saruparib if it's considered beneficial.

Potential risks and benefits

Participating in this study might offer a potential benefit if the new drug, Saruparib, slows down or helps manage your cancer, although the main goal of this particular study is to gather information about the drug rather than directly treating your cancer. There are also risks involved, as with any medical treatment. These risks could include side effects from Saruparib, which would be explained to you in detail. You would be monitored closely for any reactions. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

Research Site
Liverpool, United Kingdom· Recruiting
Research Site
Manchester, United Kingdom· Recruiting

Common questions

What is Saruparib?

Saruparib is a new drug being developed for people with advanced solid cancers. This study aims to understand how it works in the body.

Why will I be given a 'microtracer'?

A microtracer is a very tiny, safe dose of the drug with a special 'tag'. This helps researchers precisely track how the drug moves through your body and leaves it, giving them important information.

Will I have to stay in hospital?

Yes, you will need to stay in hospital for specific periods during both parts of the study so that doctors can carefully monitor you and collect samples.

What kind of samples will be collected?

Doctors and nurses will collect samples of your blood, urine, and stool (and vomit if you are sick) to see how the drug is processed and leaves your body.

What happens after the study is finished?

After you complete both parts of the study and your follow-up visit, your doctor may be able to continue giving you Saruparib if they believe it's right for you.

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.