RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia

This research study is looking at a new medicine called AZD4512 for a type of blood cancer called B-cell Acute Lymphoblastic Leukaemia (B-ALL). It's for patients whose cancer has either come back or hasn't responded to previous treatments. The study aims to find out if AZD4512 is safe, how the body handles it, and how effective it is. It will be given by itself or with other cancer drugs. The study will involve adults and young people aged 12 and above. Researchers hope to learn more about this potential new treatment option for B-ALL.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

AstraZeneca

Enrolment target

Start

12 Nov 2025

Estimated completion

03 Jul 2028

B-cell Acute Lymphoblastic Leukemia (B-ALL)

What is this study about?

This study is investigating a new medication, AZD4512, for people diagnosed with B-cell Acute Lymphoblastic Leukaemia, often shortened to B-ALL. B-ALL is a fast-growing type of blood cancer. This particular study is for patients whose B-ALL has come back after treatment (this is called 'relapsed') or hasn't responded to other treatments (this is called 'refractory'). The aim is to carefully look at how safe the drug is, what side effects it might cause, and how well it helps control the cancer.

The study has two main parts. In the first part, called 'Dose Escalation', researchers will give different doses of AZD4512 to a small number of patients to find the safest and most effective dose. In the second part, called 'Dose Optimization', more patients will receive the chosen dose to gather more information about how it works.

This research is important because it could lead to new treatment options for patients with B-ALL, especially for those whose disease has been difficult to treat with current therapies. By carefully studying AZD4512, doctors hope to offer more choices and improve outcomes for people living with this type of leukaemia.

Key takeaways

This study tests a new drug, AZD4512, for B-ALL.
It's for people whose B-ALL cancer has returned or hasn't responded to other treatments.
The study aims to understand the drug's safety and effectiveness.
You could be eligible if you're aged 12 or older with specific B-ALL conditions.
Participation involves taking the drug and regular medical checks.
You can stop participating at any time if you choose to.

Who may be eligible?

This study is looking for adults and young people with B-cell Acute Lymphoblastic Leukaemia (B-ALL) where the cancer has either returned or hasn't responded well to previous treatments. To be considered, you must have CD22-positive B-ALL.

For the first part of the study, you need to be at least 16 years old. For the second part, you can be as young as 12 years old. You must have tried at least two previous treatments for your B-ALL, or one treatment if there are no other standard options available for you. Your general health and how well you can do daily activities will also be checked, as will specific blood counts.

There are also reasons why someone might not be able to join the study. For example, if you have another type of leukaemia called Burkitt lymphoma, or if your cancer has spread to your brain or spinal cord in a specific way. Certain severe health problems, or having recently had other cancer treatments, might also mean you can't take part. The study team will review all your medical information carefully 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.

Do I have B-cell Acute Lymphoblastic Leukaemia (B-ALL) that is CD22-positive?
Has my B-ALL come back (relapsed) or not responded well to past treatments?
Am I at least 12 years old (or 16 for the first part of the study)?
Have I had at least two previous treatments for my B-ALL, or one if there are no other options?
Do I have a good enough general health status to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study drug, AZD4512, either by itself or along with other cancer medicines. The study will involve regular visits to the hospital or clinic for check-ups. During these visits, you'll have blood tests, physical examinations, and other tests to see how you're responding to the treatment and to check for any side effects. You'll also be monitored closely for a period after the treatment phase ends.

The total length of time you'll be involved in the study will depend on which part of the study you join and how you respond to the treatment. The study team will explain the full schedule of visits, tests, and medication details to you before you make a decision. You can ask them as many questions as you need to feel comfortable and informed.

Potential risks and benefits

Like all medical treatments, AZD4512 may have potential benefits and risks. The potential benefit is that this new medicine might help control your B-ALL where other treatments haven't worked or when the cancer has returned. However, there's no guarantee that it will work for everyone, and it may not be more effective than existing treatments. Potential risks include side effects from the medication, which the study will carefully monitor. You will be closely watched by the medical team, and they will fully explain all known and possible side effects before you decide to take part. It's very important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (26)

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

Research Site
Verified postcode
Duarte, United States· Recruiting
Research Site
Verified postcode
Jacksonville, United States· Withdrawn
Research Site
Verified postcode
Chicago, United States· Recruiting
Research Site
Verified postcode
Iowa City, United States· Recruiting
Research Site
Verified postcode
Franklin, United States· Recruiting
Research Site
Verified postcode
Houston, United States· Recruiting
Research Site
Verified postcode
Melbourne, Australia· Recruiting
Research Site
Verified postcode
Vancouver, Canada· Not yet recruiting
Research Site
Verified postcode
Toronto, Canada· Recruiting
Research Site
Verified postcode
Guangzhou, China· Not yet recruiting
Research Site
Verified postcode
Tianjin, China· Not yet recruiting
Research Site
Verified postcode
Bunkyō City, Japan· Recruiting

Common questions

What is B-cell Acute Lymphoblastic Leukaemia (B-ALL)?

B-ALL is a fast-growing cancer of the blood and bone marrow that affects a type of white blood cell called B-lymphocytes. These cells are important for fighting infections.

What does 'relapsed or refractory' mean?

'Relapsed' means the cancer has come back after treatment. 'Refractory' means the cancer did not respond to previous treatments.

What will happen during the study?

You will take the study medicine, AZD4512, and have regular check-ups, blood tests, and other medical exams to monitor your health and how the treatment is working.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your future medical care.

What is the purpose of testing different doses?

The study starts by testing different doses to find the safest and most effective amount of the medicine for patients.

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.