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

Recruiting now · Phase 1/Phase 2

Conditions studied: B-cell Acute Lymphoblastic Leukemia (B-ALL)

In brief

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).

Key facts

Study ID: NCT07109219
Run by: AstraZeneca
People needed: 83
Starts: 2025-11-12
Expected to finish: 2028-07-03
Last updated by the study team: 2026-07-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

1. Age:
16 years old in Module 1 (US only: ≥18year)
12 years old in Module 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
Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50)
Peripheral lymphoblast count < 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria)
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
Prior DLI >4 weeks, prior cell therapy or autoHSCT >8 weeks, alloHSCT >12 weeks

You may not qualify if…

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 disorders controlled with therapy)
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
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 it is running

Research Site — Manchester, United Kingdom (enrolling)
Research Site — Salamanca, Spain (enrolling)
Research Site — Santander, Spain (enrolling)
Research Site — Taichung, Taiwan (enrolling)
Research Site — Taipei, Taiwan (enrolling)
Research Site — Bloomsbury, United Kingdom (enrolling)
Research Site — Duarte, California, United States (enrolling)
Research Site — Chicago, Illinois, United States (enrolling)
Research Site — Iowa City, Iowa, United States (enrolling)
Research Site — Franklin, Tennessee, United States (enrolling)
Research Site — Houston, Texas, United States (enrolling)
Research Site — Melbourne, Australia (enrolling)
Research Site — Toronto, Ontario, Canada (enrolling)
Research Site — Bunkyō City, Japan (enrolling)
Research Site — Chūōku, Japan (enrolling)
Research Site — Seoul, South Korea (enrolling)
Research Site — Seoul, South Korea (enrolling)
Research Site — Seoul, South Korea (enrolling)
Research Site — Seoul, South Korea (enrolling)
Research Site — Barcelona, Spain (enrolling)
Research Site — Jacksonville, Florida, United States
Research Site — Vancouver, British Columbia, Canada
Research Site — Valencia, Spain
Research Site — Guangzhou, China
Research Site — Tianjin, China

Full record on ClinicalTrials.gov

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