RecruitingPHASE1INTERVENTIONAL

A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)

This study is investigating a new medication called AZD2962, which is designed to block a protein in the body called IRAK4. It's being tested in people in the UK who have specific types of blood cancers, such as myelodysplastic syndromes (MDS) and a form of chronic myelomonocytic leukemia (CMML). The main goals are to understand how safe the drug is, how well people tolerate it, and how the body processes it. Researchers also want to see if AZD2962 could be an effective treatment, either by itself or when used alongside other existing treatments. This initial phase of the study will focus on gradually increasing the dose of AZD2962 to find the most suitable amount.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

03 Nov 2025

Estimated completion

20 Oct 2028

Haematologic Neoplasms

What is this study about?

This research study is looking into a new experimental medicine, AZD2962, for people living with certain types of blood cancer. These include myelodysplastic syndromes (MDS) and a specific type of chronic myelomonocytic leukemia (CMML). The drug works by blocking a protein called IRAK4, which is thought to play a role in these conditions. The main purpose of the study is to find out if AZD2962 is safe to use and how well people tolerate it.

Researchers will also be closely watching how the body handles the drug, including how it's absorbed, processed, and removed. Importantly, they will also be looking for any signs that AZD2962 might be helping to treat the cancer, either on its own or when given with other established treatments. This is an early-stage study, meaning it's one of the first times this drug is being thoroughly tested in people.

The study is designed in stages. In the first stage, participants with MDS or CMML will receive AZD2962 on its own. The dose of the medicine will be gradually increased to find the safest and most effective amount. This careful approach helps the researchers understand the drug's effects step-by-step.

Key takeaways

Tests a new drug (AZD2962) for certain blood cancers.
Aims to understand safety, effects, and potential benefits.
Involves daily oral medication in 28-day cycles.
Participants will have regular check-ups and monitoring.
Focuses on people whose cancer has returned or didn't respond to previous treatments.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would generally need to be an adult between 18 and 110 years old with certain types of blood cancer, specifically myelodysplastic syndromes (MDS) or a type of chronic myelomonocytic leukemia (CMML). Your cancer would need to have come back or not responded well to previous treatments, and you should have already tried standard therapies or local treatment options.

Your general health and daily activities would need to be at a reasonable level, as determined by a medical assessment. You should also have symptoms of your disease that require treatment and can be objectively measured. Additionally, you would need to be willing to provide a bone marrow sample for the study.

There are also some reasons why you might not be able to join. For example, if you've recently had certain other cancer treatments, major surgery, or received specific medications. You also wouldn't be able to participate if you've previously taken drugs that work in a similar way to AZD2962, or if you have certain other serious medical conditions, an active major bleeding event, or have recently had live vaccines.

Quick self-check

Are you an adult aged 18 to 110?
Do you have myelodysplastic syndromes (MDS) or a type of chronic myelomonocytic leukemia (CMML) that has returned or not responded to prior treatments?
Do you feel well enough to participate in daily activities as normal, or with only minor difficulty?
Are you willing to provide a bone marrow sample?
Have you avoided certain other cancer treatments or specific medications recently?
Have you avoided other drugs that block IRAK proteins in the past?

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

What does participation involve?

If you decide to take part, the study starts with a screening period that lasts up to 21 days. During this time, you'll have various tests to make sure the study is right for you. If you're eligible, you'll then enter the treatment period. You'll take the study medication, AZD2962, as a tablet once daily. Each treatment cycle lasts for 28 days, and you'll continue treatment for as long as it's helping you and you're not experiencing difficult side effects, or until your condition progresses.

Throughout the treatment period, you'll have regular hospital visits for check-ups, blood tests, and to monitor your health and how you're responding to the treatment. These visits will be more frequent at the beginning and then become less frequent as the study progresses. After your last dose of the study drug, there will be a safety follow-up period of 30 days to check on your health and any lasting effects.

Potential risks and benefits

Participating in any clinical trial comes with potential benefits and risks. While this study is investigating if AZD2962 could be an effective treatment for your condition, there's no guarantee it will help you personally. You might not experience any direct medical benefit, and as with all medications, there's a chance of experiencing side effects, some of which could be serious. The research team will carefully monitor you for any side effects and manage them as best as possible. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (21)

Research Site
Miami, United States· Not yet recruiting
Research Site
Tampa, United States· Recruiting
Research Site
Houston, United States· Recruiting
Research Site
Heidelberg, Australia· Recruiting
Research Site
Melbourne, Australia· Recruiting
Research Site
Shinagawa-ku, Japan· Recruiting
Research Site
Yoshida-gun, Japan· Recruiting
Research Site
Seoul, South Korea· Withdrawn
Research Site
Seoul, South Korea· Withdrawn
Research Site
Barcelona, Spain· Recruiting
Research Site
Madrid, Spain· Recruiting
Research Site
Madrid, Spain· Recruiting

+9 more sites — see the official record for the full list.

Common questions

What is AZD2962?

AZD2962 is an investigational drug that works by blocking a protein called IRAK4 in the body, which is thought to be involved in certain blood cancers.

What types of cancer is this study for?

This study is for adults with specific blood cancers: myelodysplastic syndromes (MDS) and a type of chronic myelomonocytic leukemia (CMML).

What does 'monotherapy' mean?

Monotherapy means that AZD2962 will be given on its own, without other cancer treatments at the same time, during the initial part of this study.

How long would I need to take the study drug?

You would take the study drug once a day for 28-day cycles, continuing for as long as it's beneficial, well-tolerated, or until your condition changes.

Can I stop participating in the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

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.