RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression

This research is investigating a new drug called AZD3632 for people with advanced blood cancers, including acute lymphoblastic leukaemia, acute myeloid leukaemia, and higher-risk myelodysplastic syndromes. We want to understand if AZD3632 is safe, what side effects it might cause, and how effective it is in treating these conditions. The study will also look at how the body processes the drug. This drug is being tested alone or in combination with another anti-cancer medicine called Posaconazole. Participants will have specific genetic markers in their cancer cells that are linked to something called HOX overexpression. The aim is to find new and better ways to treat these types of cancer, especially when previous treatments haven't worked or have stopped working.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

AstraZeneca

Enrolment target

Start

09 Jan 2026

Estimated completion

15 Feb 2029

Acute Lymphoblastic Leukaemia Acute Myeloid Leukaemia Higher-risk Myelodysplastic Syndromes

What is this study about?

This study is looking at a new medicine called AZD3632 for people who have advanced blood cancers, specifically certain types of leukaemia (Acute Myeloid Leukaemia and Acute Lymphoblastic Leukaemia) and a condition called Myelodysplastic Syndromes (MDS). These are cancers that affect the blood and bone marrow, where blood cells are made. The study is a significant step because it's the first time this particular new medicine, AZD3632, is being tested in humans. We're trying to understand how safe it is, what side effects it might have, and if it can help treat these cancers. Importantly, we're focusing on cancers that have certain genetic changes, like KMT2Ar or NPM1m, which are thought to make the cancer grow in a particular way (called HOX overexpression).

The study has a few parts. In one part, people will receive just AZD3632 on its own to find the right dose. In another part, we'll see how AZD3632 works when given alongside another medicine called Posaconazole. This is done to understand if combining drugs can be more effective or if there are any new side effects. The overall goal is to find new and better treatment options, especially for people whose cancer hasn't responded to, or has come back after, standard treatments.

Finding new treatments is really important for people with these advanced blood cancers, especially when other options haven't worked well. This research aims to collect important information about AZD3632, to see if it could become a useful treatment in the future. It’s part of a bigger effort to improve the care and outcomes for people living with these challenging conditions.

Key takeaways

This study is testing a new drug, AZD3632, for advanced blood cancers.
It's for specific types of leukaemia and myelodysplastic syndromes with certain genetic changes.
The main goals are to check the drug's safety and how well it treats the cancer.
AZD3632 may be given alone or with another anti-cancer medicine, Posaconazole.
Participation involves regular checks and medical tests.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be at least 16 years old. Your overall health and organ function must be good enough to take part. Also, if you or your partner could become pregnant, you would need to agree to use reliable birth control methods throughout the study as advised by the doctors.

Crucially, this study is for people whose blood cancer has certain specific genetic changes, such as KMT2Ar or NPM1m, which doctors can check for. Your cancer must also be considered 'advanced', meaning it has either come back after standard treatments (relapsed) or hasn't responded to previous treatments (refractory). For example, if you have leukaemia, this means it has come back or not responded after chemotherapy or other medicines. For MDS, it means there are still a certain number of abnormal cells in your bone marrow after treatment.

Your doctor will also check that you have measurable signs of the disease and are well enough in yourself, generally with a good enough performance status and a life expectancy of at least 8 weeks. There are specific medical tests and criteria your doctor will need to review to confirm if this study is suitable for you.

Quick self-check

Are you 16 years old or older?
Do you have acute lymphoblastic leukaemia, acute myeloid leukaemia, or higher-risk myelodysplastic syndromes?
Has your cancer come back or not responded to previous treatments?
Has your doctor confirmed that your cancer has specific genetic changes (like KMT2Ar or NPM1m)?
Are you generally well enough with good organ function?
Are you able to use reliable contraception if necessary?

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

What does participation involve?

If you join this study, you'll be taking a new medicine called AZD3632, which is given by mouth. Depending on which part of the study you are in, you might receive AZD3632 on its own, or you might take it with another medicine called Posaconazole. You will have regular visits to the hospital or clinic for assessments. These will include blood tests, physical examinations, and possibly bone marrow biopsies to see how the treatment is working and to monitor your health. The medical team will closely monitor you for any side effects and to see how your body handles the medicine. The total duration of your participation will depend on how you respond to the treatment and the study's design for your specific group. There will also be follow-up appointments after you stop taking the study medicine.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. The potential benefit of this study is that AZD3632 might help to treat your cancer, especially if other treatments haven't worked well for you. However, as this is a new drug, there's always a risk of unexpected side effects, and it's not guaranteed that the treatment will work for everyone. The study team will closely monitor your health and any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

Research Site
Decatur, United States· Recruiting
Research Site
New York, United States· Not yet recruiting
Research Site
Chapel Hill, United States· Not yet recruiting
Research Site
Durham, United States· Recruiting
Research Site
Portland, United States· Not yet recruiting
Research Site
Houston, United States· Recruiting
Research Site
Fitzroy, Australia· Suspended
Research Site
Perth, Australia· Suspended
Research Site
Toronto, Canada· Suspended
Research Site
Montreal, Canada· Suspended
Research Site
Copenhagen, Denmark· Recruiting
Research Site
Dresden, Germany· Recruiting

+18 more sites — see the official record for the full list.

Common questions

What kind of cancers is this study for?

This study is for specific types of advanced blood cancers, including acute lymphoblastic leukaemia, acute myeloid leukaemia, and higher-risk myelodysplastic syndromes.

What is AZD3632?

AZD3632 is a new drug being tested in this study to see if it can treat certain blood cancers. It's an investigational medicine, meaning it's not yet available outside of clinical trials.

Why is it important that my cancer has KMT2Ar or NPM1m changes?

The study focuses on cancers with these specific genetic changes because the new drug, AZD3632, is designed to target how these particular genetic features might contribute to cancer growth.

Will I take the new drug on its own, or with another medicine?

Depending on which part of the study you join, you might receive AZD3632 on its own, or in combination with another anti-cancer medicine called Posaconazole.

Can I leave the study if I change my mind?

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