RecruitingPHASE1, PHASE2INTERVENTIONAL

A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

This research study is for adults with B-cell non-Hodgkin lymphoma, a type of blood cancer, that has either returned or not improved with previous treatments. Scientists are looking into a new medicine called AZD4512. They want to understand how safe it is and how well it works. This medicine might be given on its own or together with other cancer treatments. The study will happen in different hospitals worldwide. It's a 'Phase 1/2' study, meaning it will first check for safety and the right dose, and then look for early signs of how effective the treatment is. The initial part focuses on AZD4512 on its own for people who have had at least two previous treatments.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

AstraZeneca

Enrolment target

Start

24 Sep 2025

Estimated completion

01 Mar 2028

B-cell Non-Hodgkin Lymphoma

What is this study about?

This study is investigating a new medicine called AZD4512 for a type of blood cancer called B-cell non-Hodgkin lymphoma (B-NHL). This cancer affects your white blood cells. This particular study is for people whose B-NHL has either come back after treatment (relapsed) or has not responded to previous treatments (refractory). This means that standard treatments are no longer working well for them, and they need new options.

The main goal of this study is to find out if AZD4512 is safe and how well it works. The researchers will be looking at how the body handles the medicine, whether it causes any side effects, and if it helps to control the cancer. They will test AZD4512 as a single treatment and also in combination with other cancer medicines. This is a multinational study, meaning it's taking place in hospitals around the world.

This is a 'Phase 1/2' study. In 'Phase 1', the main aim is to check the medicine's safety and find the right dose. Once a safe dose is established, 'Phase 2' will look more closely at how effective the medicine is at treating the cancer. The study may expand in the future to look at specific types of B-NHL more closely, testing AZD4512 alone or with other drugs.

Key takeaways

This study is for adults with B-cell non-Hodgkin lymphoma that has returned or not responded to previous treatments.
It tests a new medicine called AZD4512, sometimes alone, sometimes with other drugs.
The main goals are to check the safety and potential effectiveness of AZD4512.
Participants will have regular check-ups and assessments.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be 18 years old or older and have a confirmed diagnosis of B-cell non-Hodgkin lymphoma, which means your cancer has either relapsed (come back) or is refractory (not responding to treatment). You must have tried at least two different treatments for your cancer already, and there shouldn't be other standard treatment options available that are expected to improve your survival.

There are also specific requirements depending on the type of B-NHL you have. For example, if you have a type called large B-cell lymphoma, you must have tried treatments including anti-CD20 therapy and at least one other chemotherapy, and it must not be suitable for you to have CAR-T therapy, T-cell engager therapy, or a stem cell transplant. Similar detailed criteria apply for other types of B-NHL like mantle cell lymphoma and follicular lymphoma.

There are also some things that would prevent you from joining. For example, if your B-NHL affects your brain or spinal cord, or if you have certain other conditions. You also can't have had certain other advanced therapies, like CAR-T, within 90 days of the study starting. The doctors will check your overall health, including how well your organs are working, to make sure it's safe for you 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.

Are you 18 years old or older?
Do you have B-cell non-Hodgkin lymphoma that has come back or not responded to past treatments?
Have you tried at least two different cancer treatments already?
Are there no other standard treatment options currently available for you?
Is your overall health, including organ function, considered good enough by the study doctors?
Have you *not* had advanced cell therapies (like CAR-T) in the last 3 months?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for check-ups and to receive the study medicine, AZD4512. You would have various assessments, such as blood tests, scans, and physical examinations, to monitor your health, how your body reacts to the medicine, and how your cancer is responding. The treatment could involve taking AZD4512 either on its own or together with other cancer medications. The doctors and study team will explain the full schedule of visits and tests. You would be followed closely by the study team, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Potential risks and benefits

Like all medical treatments, AZD4512 may have potential benefits, such as helping to control your cancer when other treatments haven't worked. However, it may also have side effects, as it is a new medicine being tested. The study team will closely monitor you for any side effects and provide care. You will be given detailed information about all known risks and potential side effects before you decide to join. Remember, your participation is voluntary, and you can choose to leave the study at any time without giving a reason, which will not affect your relationship with your doctors or your future medical care.

Locations (22)

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

Research Site
Verified postcode
Irvine, United States· Recruiting
Research Site
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Jacksonville, United States· Recruiting
Research Site
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Rochester, United States· Recruiting
Research Site
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New York, United States· Recruiting
Research Site
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New York, United States· Recruiting
Research Site
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Cleveland, United States· Withdrawn
Research Site
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Myrtle Beach, United States· Withdrawn
Research Site
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Franklin, United States· Recruiting
Research Site
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Melbourne, Australia· Recruiting
Research Site
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Chengdu, China· Not yet recruiting
Research Site
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Guangzhou, China· Not yet recruiting
Research Site
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Bologna, Italy· Recruiting

Common questions

What is B-cell non-Hodgkin lymphoma?

It's a type of cancer that starts in the B-cells, which are white blood cells that help your body fight infection. These cells become abnormal and grow out of control.

What does 'relapsed/refractory' mean?

It means your cancer has either come back after previously getting better with treatment (relapsed) or it hasn't responded to the treatments you've already had (refractory).

What is AZD4512?

AZD4512 is the name of the new experimental medicine being tested in this study. It's not yet approved for general use, and researchers are studying how it works.

What is a Phase 1/2 study?

This type of study first checks if the new medicine is safe and helps find the right dose (Phase 1). After that, it looks for early signs of whether the medicine is effective at treating the cancer (Phase 2).

Will I get AZD4512 or another drug?

The study will test AZD4512 on its own or in combination with other cancer medicines. The specific treatment plan will be discussed with you by the study team.

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.