ALLight
Research type
Research Study
Full title
A Modular Phase I/II, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AZD4512 Monotherapy or in Combination With Anticancer Agent(s) in Participants with Acute Lymphoblastic Leukemia
IRAS ID
1011961
Contact name
Juliet Wou
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Researchers are studying a new medicine called, AZD4512, to find better ways to treat B-cell acute lymphoblastic leukaemia (B-ALL), a blood cancer that begins in the bone marrow when immature white blood cells known as lymphoblasts start to grow abnormally. When these cells grow too quickly, there aren’t enough healthy blood cells. This can cause bruising, bleeding, bone pain, infections, and tiredness. Current treatments for B-ALL, like chemotherapy and immunotherapy, may not be effective for everyone. This means that the cancer may not respond to treatment or may come back after an initial response. That’s why new treatments like AZD4512 are being explored. AZD4512 is an antibody-drug conjugate, which means it combines a targeted antibody with chemotherapy. AZD4512 targets B-ALL cells carrying a protein called CD22. Once attached, AZD4512 delivers chemotherapy directly into the cancer cell to destroy it. This is the first time AZD4512 is being tested in people, in a phase 1/2 ‘open label’ trial, where both participants and doctors will know what treatment is being given. The main aims are to see how safe AZD4512 is, how well it works and how the body handles the drug. About 120 people with B-ALL, whose cancer has come back or hasn’t improved with other treatments will join. The study has 2 parts (modules): Module 1 includes people aged 16 and older, regardless of whether they have a genetic change called the Philadelphia chromosome. Module 2 includes people aged 12 and older without this genetic change. The Philadelphia chromosome is an alteration in the leukaemia cell’s DNA. Different doses of AZD4512 will be tried, given as an IV drip, to find the safest and most effective dose. Participants will keep getting the medicine until their cancer worsens, the side effects become too much, or they decide to stop. Throughout the study, researchers will closely monitor for side effects and changes in health and in Module 2, they will see how well treatment is working.
REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0094
Date of REC Opinion
29 Sep 2025
REC opinion
Further Information Favourable Opinion