RecruitingPHASE1INTERVENTIONAL

A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy

This research study is investigating a new way to deliver a cancer treatment called rilvegostomig. Currently, this type of medicine is often given directly into a vein (intravenously). This study aims to find the right dose of a subcutaneous (under-the-skin) injection of rilvegostomig, potentially combined with another substance called hyaluronidase, to see if it works as well as the intravenous method. The study will also check how safe this new way of giving the medicine is. It's for adults with advanced solid tumours who have already received standard treatments, and whose doctors think an immunotherapy treatment like rilvegostomig could be suitable for them. The goal is to make treatments more convenient for patients.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

25 Nov 2025

Estimated completion

24 Jul 2029

Advanced Solid Tumors

What is this study about?

This study is exploring a new way to give a cancer medicine called rilvegostomig. Many cancer treatments are currently given through a drip into a vein (intravenously), which can take time and often requires visits to a hospital or clinic. This research aims to see if rilvegostomig can be given as a simple injection under the skin (subcutaneously) instead. This could make the treatment much more convenient for patients, potentially allowing for easier administration.

The main goal of the study is to find the right amount of rilvegostomig to give as a subcutaneous injection so that it has a similar effect in the body as when it's given into a vein. It will also look at whether combining rilvegostomig with another substance, recombinant human hyaluronidase (rHu), helps with the absorption of the medicine when given under the skin. A big part of the study is also to carefully check for any side effects and to make sure the subcutaneous injection is safe.

This is an early-stage (Phase 1) study involving adults with advanced solid tumours. These are cancers that have grown or spread, and the participants in this study would have already had standard treatments. Their doctors would also need to feel that a type of treatment called immunotherapy, which helps the body's own immune system fight cancer, is a suitable option for them. Finding a simpler way to administer effective treatments like this could significantly improve the experience for people living with cancer.

Key takeaways

This study is testing a new way to give an existing cancer treatment (rilvegostomig) as an injection under the skin.
The main goal is to find a safe and effective subcutaneous dose that works as well as the current intravenous method.
It's for adults with advanced solid cancers who have already received standard treatments.
Participation involves receiving rilvegostomig (either IV or SC) and regular health checks.
The study aims to make cancer treatment more convenient for patients.
All side effects will be carefully monitored by the study team.

Who may be eligible?

To join this study, you must be an adult with a solid tumour that is advanced (meaning it has spread or can't be removed with surgery). You would also need to have already received some standard cancer treatments for your condition.

Your doctor would need to agree that an immunotherapy treatment could be a good choice for you. You should be generally well enough to take part, meaning you can carry out most of your daily activities with little to no difficulty, and your important organs (like your liver and kidneys) are working well. You must also weigh at least 30 kg.

There are also some reasons why you wouldn't be able to join. These include having other serious uncontrolled illnesses, a history of organ transplant, certain autoimmune conditions, specific heart problems, uncontrolled infections like HIV or hepatitis, or if you've had another type of cancer in the last two years. Also, if side effects from previous cancer treatments are still severe (apart from hair loss), you wouldn't be able to participate. It's important to discuss your full medical history with the study team to see if this study is right 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 an adult with an advanced solid tumour?
Have you already received standard treatments for your cancer?
Does your doctor think an immunotherapy might be suitable for you?
Are you generally well and able to carry out most daily activities?
Do you have good overall organ function and no severe, uncontrolled illnesses?
Do you weigh at least 30 kg?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study medication, rilvegostomig, either into a vein (intravenously) or as an injection under the skin (subcutaneously), potentially with human hyaluronidase. The study has two main parts. The first part will test different doses of the subcutaneous injection to find the one that matches the effect of the intravenous treatment. Once that dose is found, the second part will continue to evaluate its safety and how well it is absorbed. You will have regular visits to the clinic for assessments, which will include blood tests to check how the medicine is working in your body, and thorough checks for any side effects. The total duration of your participation will depend on the specific part of the study you are in and how you respond to the treatment.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you would receive a new cancer treatment, rilvegostomig, which might help manage your advanced solid tumour. You would also be contributing to medical knowledge that could make future cancer treatments more convenient for patients. However, as with any new treatment, there are potential risks, including side effects from the medication. The study team will closely monitor you for any side effects and will explain all known risks before you make a decision. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (11)

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

Research Site
Verified postcode
Huntersville, United States· Recruiting
Research Site
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San Antonio, United States· Recruiting
Research Site
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Fairfax, United States· Recruiting
Research Site
Verified postcode
Seoul, South Korea· Not yet recruiting
Research Site
Verified postcode
Seoul, South Korea· Not yet recruiting
Research Site
Verified postcode
Barcelona, Spain· Not yet recruiting
Research Site
Verified postcode
Barcelona, Spain· Recruiting
Research Site
Verified postcode
Madrid, Spain· Recruiting
Research Site
Verified postcode
Madrid, Spain· Recruiting
Research Site
Verified postcode
Newcastle upon Tyne, United Kingdom· Suspended
Research Site
Verified postcode
Sutton, United Kingdom· Suspended

Common questions

What is a 'solid tumour'?

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Examples include breast cancer, lung cancer, and bowel cancer, as opposed to blood cancers like leukaemia.

What does 'immunooncology (IO) monotherapy' mean?

Immunooncology, or immunotherapy, is a type of treatment that helps your body's own immune system fight cancer. 'Monotherapy' means you would receive this treatment on its own, not in combination with other anti-cancer drugs.

What does 'subcutaneous' and 'intravenous' mean?

'Subcutaneous' means an injection given just under the skin, like an insulin shot. 'Intravenous' means an injection or drip given directly into a vein, usually in your arm.

Will I know if I'm getting the intravenous or subcutaneous medicine?

Yes, this is an 'open-label' study, which means both you and your study doctor will know which form of the medicine (intravenous or subcutaneous) you are receiving.

What does 'Pharmacokinetics (PK)' mean?

Pharmacokinetics is how the body handles a medicine – how it's absorbed, distributed, broken down, and removed. This study wants to see if the under-the-skin injection gets into your system in a similar way to the traditional vein infusion.

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.