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Study of AZD4512 for B-cell Acute Lymphoblastic Leukemia

This study is testing AZD4512, a treatment that targets CD22, in people with B-cell Acute Lymphoblastic Leukemia (B-ALL) that has come back or not responded to previous treatments. Researchers want to see how safe AZD4512 is, how well your body handles it, and if it helps treat the leukemia. You might receive AZD4512 alone. To join, you must have CD22-positive B-ALL and be at least 12 or 16 years old, depending on the study part. The main goals are to track any side effects and how often they happen.

Study design
This is an open-label study, meaning you and your doctors will know what treatment you are receiving. It plans to enroll 83 participants and has two parts: dose escalation and dose optimization.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects from the first dose up to 30 days after your last dose of AZD4512, which is expected to be around 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07109219

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

Recruiting
PHASE1Ages 12+InterventionalTreatment
AstraZeneca
~83 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:AZD4512 monotherapy

At a glance

Recruiting sites
20 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Module 1 (Dose Escalation): Number of participants with dose-limiting toxicities (DLTs).
Measured over From first dose up to 21 days (DLT period).
+7 more outcomes measured

Conditions

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Explore related trials

B Acute Lymphoblastic LeukemiaCD22 Gene

Where it's being run

26 sites across 15 states
Spain5
South Korea4
China2
Japan2
Taiwan2
United Kingdom2
California1
Florida1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

1\. Age:
16 years old in Module 1 (US only: ≥18year)
12 years old in Module 2
Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance of blasts in PB)
Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R/R
Backfill of Module 1 and Module 2 (DO): R/R Ph(-) B-ALL
Ph+ B-ALL (Module 1 DE only): intolerant to or have contraindications to TKI therapy or R/R disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI

Exclusion

Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction)
Biologic (immuno-oncology) treatment within 28 days or 5 half-lives (whichever is shorter)
Non-CNS radiation within 2 weeks \& CNS radiation within 4 weeks
Medications known to prolong QTc and/or associated with Torsades de Pointes within 5 half-lives
Strong inhibitors of CYP 3A4 within 14 days or 5 half-lives (whichever is longer)
Investigational agents or study interventions in the last 30 days or 5 half-lives prior to the first dose of AZD4512 whichever is longer. If the investigational product is an agent to treat B-ALL and meets the modality criteria, then a specific washout period must be adhered to instead.

What this trial measures

  • Module 1 (Dose Escalation): Number of participants with dose-limiting toxicities (DLTs).From first dose up to 21 days (DLT period).

    DLTs are dose-limiting toxicities as defined in the study protocol.

  • Module 1 (Dose Escalation): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)

    Assessed by the CTCAE criteria version 5.0

  • Module 1 (Dose Escalation): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEsFrom date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
  • Module 1 (Dose Escalation): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signsFrom date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
  • Module 2 (Dose Optimization): Overall response rate (ORR) in participants with R/R Ph(-) B-ALLFrom date of first dose of AZD4512 up until end of study, up to 38 months

    To evaluate the efficacy based on NCCN response criteria, measured by ORR (CR/CRh)

  • Module 2 (Dose Optimization): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs)From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)

    Assessed by the CTCAE criteria version 5.0

  • Module 2 (Dose Optimization): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEsFrom date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
  • Module 2 (Dose Optimization): Number of participants with clinically significant changes in laboratory values, ECGs, performance status, and vital signsFrom date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)