Tests AZD4512 alone or with other cancer drugs in acute lymphoblastic leukemia

Trial details

Who runs it

AstraZeneca

Trial code

NCT07109219EU 2025-522372-93-00

Record updated

15 October 2026

Original description

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).Read full original descriptionShow less

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

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).

Inclusion: 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); All Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts > 5% or reappearance of blasts in PB); Module 1 (DE): R/R B-ALL [Ph(-) and Ph(+)]; Backfill of Module 1 and Module 2 (DO): R/R B-ALL [Ph(-)] with demonstration of CD22 expression by local assessment in screening; Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50); Peripheral lymphoblast count < 10,000/µL (may receive cytoreduction prior to C1D1 per protocol-specified criteria); Prior therapies:; Module 1 (DE): At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. For Ph+ B-ALL: 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; Backfill of Module 1 (backfills) and Module 2 (DO): at least one prior line of therapy (SOC or clinical trial) to which the participant has been either refractory or has subsequently relapsed; Participants who have received prior CD22 targeted therapies and were not refractory to these therapies are eligible; Prior DLI >4 weeks, prior cell therapy or autoHSCT >8 weeks, alloHSCT >12 weeks.

Exclusion: 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; Burkitt lymphoma and leukemia.

ClinicalTrials.gov NCT07109219 · EU CTIS 2025-522372-93-00