Recruiting
Phase 1
Phase 2

AZD4512

Sponsor:

AstraZeneca

Code:

NCT07109219

Conditions

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

AZD4512 monotherapy

Study Details

Brief 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).

Conditions

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Study ID

NCT07109219

Start date

Nov 12, 2025

Status verified date

Jul, 2026

Completion date

Jul 3, 2028

Anticipated

Primary completion date

Apr 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

83 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Module 1 Dose Escalation

Module 1 will evaluate escalating doses of AZD4512 as monotherapy to determine the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in Module 2 (dose optimization), in participants with relapsed/refractory (R/R) Philadelphia chromosome positive (Ph\[+\]) and negative (Ph\[-\]) B-ALL, R/R as defined by National Comprehensive Cancer Network (NCCN) guidelines.

experimental: Module 2 Dose Optimization

Module 2 will randomize participants with R/R (as defined by NCCN guidelines) Ph(-) BALL only across 2 to 3 dose levels identified in Module 1 to receive AZD4512 monotherapy for further exploration of the doses. The aim of Module 2 is to identify the recommended Phase 2 dose (RP2D) of AZD4512 monotherapy, evaluate the efficacy and further define the safety profile of AZD4512.

Interventions

AZD4512 monotherapy

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

Primary outcome measure

  • Module 1 (Dose Escalation): Number of participants with dose-limiting toxicities (DLTs). [ Time Frame: From first dose up to 21 days (DLT period). ]
  • Module 1 (Dose Escalation): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs) [ Time Frame: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months) ]
  • Module 1 (Dose Escalation): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From date of first dose of AZD4512 up until end of study, up to 38 months ]
  • Module 2 (Dose Optimization): Frequency, duration and severity of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs) [ Time Frame: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months) ]
  • Module 2 (Dose Optimization): Frequency of dose interruptions, modifications, delays, and discontinuations due to AEs [ Time Frame: 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 [ Time Frame: From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Duarte, California, United States, 91010

Research Site

Recruiting

Chicago, Illinois, United States, 60611

Research Site

Recruiting

Iowa City, Iowa, United States, 52242

Research Site

Recruiting

Franklin, Tennessee, United States, 37067

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 1X6

More Information

Sponsor

AstraZeneca

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Acute lymphoblastic leukemia (B-ALL)
  • Dose escalation
  • Dose optimization
  • Cluster of differentiation 22 (CD22)
  • Antibody-drug conjugate (ADC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-13.