RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours

This research study is looking into a new medication called AZD4956. We want to understand if it's safe and how well it works, both on its own and when combined with another anti-cancer medicine called Saruparib. The study is for people who have advanced or metastatic solid tumours, especially those with specific genetic differences that affect how their cells repair damage. Researchers will start by giving different doses to a small group of patients to find the safest amount, and then expand to more patients to learn more about the medicine's effects. The main goal is to find new ways to treat these types of cancers more effectively.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

AstraZeneca

Enrolment target

180

Start

17 Mar 2026

Estimated completion

29 Mar 2030

Solid Tumours

What is this study about?

This research study is looking at a new potential treatment called AZD4956 for people with certain advanced or metastatic solid tumours. 'Advanced' means the cancer has grown beyond where it started, and 'metastatic' means it has spread to other parts of the body.

The study has two main parts. In the first part, researchers are checking if AZD4956 on its own is safe and how the body handles it. In the second part, they are combining AZD4956 with another anti-cancer medicine called Saruparib to see if together they work better. The hope is to find out if these medicines can stop or slow down cancer growth while being manageable for patients. This is one of the first times this new medicine is being tested in people.

Doctors are particularly interested in tumours with specific 'homologous recombination repair (HRR) deficiencies'. This is a fancy way of saying that the cancer cells have trouble fixing their DNA, which might make them more vulnerable to these new treatments. By understanding how AZD4956 works with or without Saruparib in these specific types of tumours, researchers hope to develop more targeted and effective treatment options for the future.

Key takeaways

It's a study for adults with advanced solid tumours, some with specific genetic changes.
It's testing a new medicine, AZD4956, alone and with Saruparib.
The main goals are to check safety and how well the treatment works.
Participation involves regular clinic visits, tests, and closely monitoring your health.
You can stop participating in the study at any time.
This is an early-stage study, meaning the medicine is still being researched.

Who may be eligible?

To join this study, you must be an adult aged 18 or older with a locally advanced or metastatic solid tumour. You should generally be well enough to take part in daily activities, meaning you have a good 'performance status', and doctors expect you to live for at least 12 weeks. Your body's organs, like your kidneys and liver, must be working well, and if you are a woman, you must not be pregnant, breastfeeding, or planning to donate eggs during the study and for about 6 months afterwards.

For the part of the study testing AZD4956 on its own, your cancer must have shown some growth, and you might have had treatment with a specific type of medicine called a PARP inhibitor before. For the part of the study combining AZD4956 with Saruparib, you need to have specific types of advanced cancer, such as certain breast, ovarian, fallopian tube, peritoneal, prostate, or pancreatic cancers, and your cancer must be measurable. Depending on the exact part of the study, you might not have received a PARP inhibitor before.

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 or metastatic solid tumour?
Are you generally well and able to manage daily activities?
Are your body's main organs (like liver, kidneys) working properly?
If you are a woman, are you definitely not pregnant or breastfeeding, and not planning to during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medicine, AZD4956 (either on its own or with Saruparib), for a period of time. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to see how the medicine is affecting your cancer and your overall health. These visits will help the doctors understand if the treatment is safe and working. You may also be asked to provide biopsies (small tissue samples). The study will involve ongoing follow-up to monitor your health. The total duration of your participation will depend on how you respond to the treatment and the study plan, but there will be ongoing observation.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as access to a new treatment before it's widely available, which might help your cancer. However, there are also potential risks; new medicines can have side effects that doctors don't fully know yet. You might experience common side effects, or less common, more serious ones. You will be closely monitored, and doctors will explain all known risks. It's very important to remember that you can decide to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

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

Research Site
Verified postcode
New York, United States· Not yet recruiting
Research Site
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Providence, United States· Not yet recruiting
Research Site
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Houston, United States· Not yet recruiting
Research Site
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Fairfax, United States· Recruiting
Research Site
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Melbourne, Australia· Not yet recruiting
Research Site
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Westmead, Australia· Not yet recruiting
Research Site
Verified postcode
Chūōku, Japan· Not yet recruiting
Research Site
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Kashiwa, Japan· Not yet recruiting
Research Site
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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· Not yet recruiting

Common questions

What kind of cancers are included in this study?

This study is for people with advanced or metastatic solid tumours, including certain types of breast, ovarian, prostate, and pancreatic cancers. It specifically looks at tumours with certain genetic changes.

What is AZD4956?

AZD4956 is a new medicine being tested. It's an experimental drug, which means it's not yet approved for public use.

What are 'solid tumours'?

Solid tumours are abnormal masses of tissue that usually don't contain liquid or cysts. They are different from blood cancers like leukaemia.

Will I get AZD4956 on its own or with another medicine?

The study has different parts. Some patients will receive AZD4956 alone, while others will receive it in combination with another anti-cancer medicine called Saruparib. Which one you get will depend on your specific condition and the study plan.

How long will I be in the study?

The length of your participation will vary. You will have regular check-ups and follow-up, and your involvement will continue as long as the treatment is benefiting you, or until other reasons require you to stop.

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.