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Clinical Trials in Spain / NCT07109219
Recruiting Phase 1/2

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

NCT07109219 · tracked via the Priya Life Science Spain tracker
Sponsor
AstraZeneca
Phase
Phase 1/2
Started
2025-11-12
Last updated
2026-07-13

Condition(s) studied

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Investigational drug(s) / intervention(s)

AZD4512 monotherapy

AZD4512 monotherapy: Patients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22

Study summary

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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 AEs — From 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 signs — From 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-ALL — From 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 AEs — From 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 signs — From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)

Trial sites (26)

FacilityCityRegionStatus
Research Site Duarte California Recruiting
Research Site Jacksonville Florida Withdrawn
Research Site Chicago Illinois Recruiting
Research Site Iowa City Iowa Recruiting
Research Site Franklin Tennessee Recruiting
Research Site Houston Texas Recruiting
Research Site Melbourne Australia Recruiting
Research Site Vancouver British Columbia Not Yet Recruiting
Research Site Toronto Ontario Recruiting
Research Site Guangzhou China Not Yet Recruiting
Research Site Tianjin China Not Yet Recruiting
Research Site Bunkyō City Japan Recruiting
Research Site Chūōku Japan Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Recruiting
Research Site Badalona(Barcelona) Spain Not Yet Recruiting
Research Site Barcelona Spain Recruiting
Research Site Salamanca Spain Recruiting
Research Site Santander Spain Recruiting
Research Site Valencia Spain Withdrawn
Research Site Taichung Taiwan Recruiting
Research Site Taipei Taiwan Recruiting
Research Site Bloomsbury United Kingdom Recruiting
Research Site Manchester United Kingdom Recruiting

More AstraZeneca trials in Spain

PASS of Paediatric Patients Initiating Selumetinib Active, not recruiting
Study of AZD0754 in Participants With Metastatic Prostate Cancer Recruiting
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer Recruiting
A Phase III Study to Assess the Effect of AZD0780 on LDL-C in Patients With HeFH Active, not recruiting
A Study to Investigate Efficacy and Safety of AZD1163 in Participants With Rheumatoid Arthritis Recruiting

Other trials for the same condition

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies Active, not recruiting
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07109219 on ClinicalTrials.gov ↗ ← All trials in Spain