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Looking for participantsPhase1/Phase2

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

Sponsor: AstraZeneca

NCT ID: NCT07109219

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD4512 monotherapy (combination product)
How long the study runs
Study runs about 32 months (dates as stated)
About the drug or intervention
AZD4512 monotherapy — combination product: Patients will receive AZD4512 as monotherapy via intravenous infusion.
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by AstraZeneca, is testing a drug called AZD4512 on its own or with other anti-cancer medicines in people with B-cell acute lymphoblastic leukaemia (B-ALL) that has come back (relapsed) or has not responded to treatment (refractory). B-ALL is a cancer of a type of white blood cell called B cells, and in this trial the cancer cells must carry a marker called CD22.

Who can take part

  • Age 16 or over in Module 1 (in the US, 18 or over), or age 12 or over in Module 2
  • A diagnosis of CD22-positive B-cell acute lymphoblastic leukaemia, based on World Health Organization criteria
  • Leukaemia that has relapsed (come back) or is refractory (did not respond to treatment)
  • At least 2 previous treatments that failed, or 1 previous treatment that failed with no standard options left; people who have had CD22-targeted treatments before can still take part
  • For a subtype called Ph+ B-ALL (Module 1 only): unable to tolerate drugs called TKIs, or the disease came back despite at least 2 TKIs or one 3rd-generation TKI
  • Well enough for the study (measured by performance scores) and not too many leukaemia cells in the blood (some reduction treatment beforehand may be allowed)
  • Enough time must have passed since previous cell therapy, donor cell infusion, or stem cell transplants (4, 8 or 12 weeks depending on the type)

Who may not be able to

  • Having Burkitt lymphoma or leukaemia
  • Cancer only outside the bone marrow, or active disease in the brain, spinal cord or testicles
  • Ongoing side effects from earlier treatment that are Grade 2 or worse (with some exceptions, such as hair loss)
  • A history of drug-induced lung inflammation (called ILD or pneumumonitis) that needed steroid tablets or drip, oxygen, or where it cannot be ruled out on scans
  • Recent anti-cancer treatment: chemotherapy within 14 days, immunotherapy within 28 days or 5 half-lives, radiotherapy within 2-4 weeks, or other experimental drugs within 30 days or 5 half-lives
  • Recent use of certain medicines, including drugs that affect heart rhythm (QTc) or strong blockers of a liver enzyme called CYP3A4

What taking part involves

  • • Taking the study drug AZD4512 on its own
  • • Taking AZD4512 together with other anti-cancer medicines
  • • The study has parts called Module 1 and Module 2 covering slightly different types of B-ALL

Time commitment: Not stated — ask the trial team about how long the study lasts, how often visits happen, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
83
Started
2025-11-12
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for b-cell acute lymphoblastic leukemia (b-all)
  • • Phase1/Phase2 - 83 participants
  • • The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL)

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with b-cell acute lymphoblastic leukemia (b-all)

Where?

  • • Bloomsbury - Research Site
  • • Manchester - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).

More detail

In this Phase I/II, open-label multi-center study AZD4512 will be administered to adult/young adult patients (Module 1: \>=16 years; Module 2: \>=12 years) with relapsed/refractory B-Cell acute lymphoblastic leukemia (B-ALL). This study will have 2 parts: Module 1 - Dose Escalation and Module 2 - Dose Optimization.

B-cell Acute Lymphoblastic Leukemia (B-ALL)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders
  • How fit you need to be: ECOG 2 or better

Biomarkers mentioned

CD22

Treatment history

Treatments you must have had:

  • ✓ refract

What the study is looking for

  • ✓1\. Age:
  • ✓16 years old in Module 1 (US only: ≥18year)
  • ✓12 years old in Module 2
  • ✓2\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022).
  • ✓Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \> 5% or reappearance...

Who cannot take part

  • ✗Burkitt lymphoma and leukemia
  • ✗Isolated extramedullary disease; Active testicular or CNS (\> CNS1) involvement
  • ✗Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine...
  • ✗History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where...
  • ✗Prior/concomitant therapy
See the full criteria
Inclusion Criteria: * 1\. Age: * 16 years old in Module 1 (US only: ≥18year) * 12 years old in Module 2 2\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022). * 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 3\. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50) 4\. Peripheral lymphoblast count \< 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria) 5\. At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. Participants who have received prior CD22 targeted therapies are eligible. * 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 6\. Prior DLI \>4 weeks, prior cell therapy or autoHSCT \>8 weeks, alloHSCT \>12 weeks Exclusion Criteria: 1. Burkitt lymphoma and leukemia 2. Isolated extramedullary disease; Active testicular or CNS (\> CNS1) involvement 3. Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy) 4. History of drug-induced non-infectious ILD/pneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening 5. Prior/concomitant therapy * 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.

Where Is This Study? (2 UK sites)

Research Site

Bloomsbury W1T 7HA, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07