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AZD4512

Clinical trials are studying AZD4512 in people with B-cell blood cancers. These studies aim to learn about safety, tolerability, and how well AZD4512 may work in non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia. The trials include adults with relapsed or refractory disease, meaning the cancer came back or did not respond well to past treatment.

Table of Contents

Trials overview

Two authorised interventional studies are investigating AZD4512 in people with B-cell blood cancers.[1][2] Both studies are Phase 1/2 trials, which means they first look at safety and dose, and then also look for early signs that the treatment may help.[1][2]

AZD4512 study in B-cell non-Hodgkin lymphoma

The first trial is studying AZD4512 in people with B-cell non-Hodgkin lymphoma (B-NHL).[1] Its title says the researchers want to learn how safe AZD4512 is, both with and without other cancer drugs, and how it works in the bodies of people with B-NHL.[1]

The brief summary says the main goal is to assess the safety and tolerability of AZD4512 used by itself in participants with relapsed or refractory B-NHL, and to establish the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD).[1] Relapsed means the cancer came back after treatment, and refractory means it did not respond well to treatment.[1]

This study plans to enroll 99 people.[1] The treatment is AZD4512 given as an IV infusion, which means it is delivered through a vein.[1]

AZD4512 study in B-cell acute lymphoblastic leukemia

The second trial is studying AZD4512 in people with B-cell acute lymphoblastic leukemia (B-ALL).[2] Its title says the researchers want to learn how safe AZD4512 is and how it works in the bodies of people with B-ALL.[2]

This study has two parts, called Module 1 Dose Escalation and Module 2 Dose Optimization.[2] In Module 1, the trial includes people with relapsed or refractory B-ALL, both Ph(-) and Ph(+), according to NCCN guidelines.[2] In Module 2, the trial focuses on relapsed or refractory Ph(-) B-ALL and looks more closely at how well AZD4512 may work.[2]

The study plans to enroll 83 people and also uses AZD4512 as an IV infusion.[2] In the dose optimization part, the researchers aim to determine the recommended phase 2 dose (RP2D), which is the dose chosen for later studies after safety and early results are reviewed.[2]

What the trials measure

Both trials focus on safety first.[1][2] The lymphoma study measures the percentage of participants with dose-limiting toxicities (DLT), the frequency, duration, and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs), plus side effects that lead to stopping treatment, and clinically important changes in vital signs and laboratory tests.[1]

The leukemia study measures similar safety items, including DLTs, TEAEs, TRAEs, SAEs, treatment interruptions, dose changes, delays, discontinuations, and clinically important changes from baseline, which means changes from the first measurement taken before treatment started.[2]

The leukemia study also measures antitumour activity, which means early signs that the treatment may reduce the cancer.[2] Its main response measure is objective response rate (ORR), including complete response (CR) and complete response with partial hematologic recovery (CRh).[2]

Who may be able to join

Based on the trial data, the studies are for people with B-cell blood cancers that have come back or have not responded well to earlier treatment.[1][2] The lymphoma study is for participants with relapsed or refractory B-NHL, and the leukemia study is for participants with relapsed or refractory B-ALL.[1][2]

The leukemia trial has a broader group in the first module because it includes both Ph(-) and Ph(+) B-ALL, while the second module focuses on Ph(-) B-ALL only.[2] Ph(-) and Ph(+) are labels used in leukemia to describe whether a specific chromosome change is present or not.[2]

Trial phases and what they mean

Both studies are in Phase 1/2, which is common for early cancer research.[1][2] Phase 1 parts are mainly about safety, side effects, and finding the right dose, while Phase 2 parts look more closely at whether the treatment may help the cancer.[1][2]

In the leukemia study, the dose escalation part is used to find the MTD and doses to explore later, and the dose optimization part is used to help choose the RP2D and assess early efficacy.[2] In the lymphoma study, the researchers aim to find the MTD and/or OBD while studying safety and tolerability.[1]

Trial ID Phase Condition studied Status Enrollment
2025-522371-29-00 Phase 1/2 Non-Hodgkin lymphoma (B-cell non-Hodgkin lymphoma) Authorised 99
NCT07109219 Phase 1/2 B-cell acute lymphoblastic leukemia Authorised 83

FAQ

  • What is being studied in AZD4512 trials? The trials are looking at AZD4512 in people with B-cell blood cancers. They measure safety, tolerability, and early signs of antitumour activity, which means whether the treatment may help fight the cancer.
  • Who can take part in these trials? The studies include people with relapsed or refractory B-cell non-Hodgkin lymphoma and people with relapsed or refractory B-cell acute lymphoblastic leukemia. One trial includes both Ph(-) and Ph(+) B-ALL in dose escalation, while dose optimization focuses on Ph(-) B-ALL.
  • What phase are the AZD4512 trials? Both trials are <b>Phase 1/2</b> studies. This means they are early studies that first look at safety and dosing, and then may look for early signs that the treatment works.
  • What do the trials measure? The trials measure dose-limiting toxicities, treatment-related side effects, serious side effects, changes in vital signs, and lab test changes. The leukemia trial also measures response rate, including complete response and complete response with partial blood count recovery.
  • Are these trials testing AZD4512 alone or with other cancer drugs? The lymphoma trial says AZD4512 is being studied with and without other cancer drugs, but its brief summary focuses on AZD4512 monotherapy, which means AZD4512 used by itself. The leukemia trial focuses on AZD4512 given as an IV infusion.

Ongoing Clinical Trials on AZD4512

  • A Study of AZD4512 Alone or With Other Cancer Drugs for People With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • A Study to Test the Safety and How AZD4512 Works in Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • B-cell non-Hodgkin lymphoma (B-NHL): A group of cancers that start in B cells, which are a type of white blood cell. Non-Hodgkin lymphoma is a broad name for many related lymph node and blood cancers.
  • B-cell acute lymphoblastic leukemia (B-ALL): A fast-growing blood cancer that begins in early B cells. It affects the bone marrow and blood.
  • Relapsed disease: Cancer that came back after treatment.
  • Refractory disease: Cancer that did not respond well to treatment or stopped responding.
  • Phase 1/2: An early stage of clinical research. Phase 1 mainly checks safety and dose, and Phase 2 looks more closely at whether the treatment shows signs of working.
  • Interventional study: A study where researchers give a treatment to see what happens.
  • IV infusion: A treatment given through a vein, usually slowly over time.
  • Dose-limiting toxicity (DLT): A side effect that is serious enough to limit how much of the treatment can be given.
  • Treatment-emergent adverse event (TEAE): Any unwanted medical problem that starts or gets worse after treatment begins.
  • Treatment-related adverse event (TRAE): A side effect that the study team thinks may be caused by the treatment.
  • Serious adverse event (SAE): A serious health problem during a study, such as one that is life-threatening, needs hospital care, or causes major harm.
  • Objective response rate (ORR): The percentage of people whose cancer shrinks or disappears based on study rules.
  • Complete response (CR): No clear signs of cancer are found after treatment.
  • Complete response with partial hematologic recovery (CRh): A very strong response where the cancer is not seen, and blood counts recover partly but not fully.
  • Maximum tolerated dose (MTD): The highest dose of a treatment that can be given without too many serious side effects.
  • Recommended phase 2 dose (RP2D): The dose researchers choose for later studies after looking at safety and early results.

References