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AZD4512 monotherapy

Phase 1

B-cell Acute Lymphoblastic Leukemia (B-ALL) | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 11, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment83
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07109219Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic LeukemiaPHASE1 RECRUITING 83 — — Nov 12, 2025Jul 3, 2028May 11, 202626 United States, Australia +7
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Study Endpoints
Primary Endpoints
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)
Secondary Endpoints
Module 1 (Dose Escalation): Plasma PK parameters of AZD4512
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
Module 1 (Dose Escalation): Total antibody and total unconjugated payload
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
Module 1 (Dose Escalation): Area Under Curve (AUC)
From date of first dose of AZD4512 up until 30 days post last dose of AZD4512 (on average 6 months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1 Dose EscalationEXPERIMENTALModule 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.
Module 2 Dose OptimizationEXPERIMENTALModule 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
NameTypeDescription
AZD4512 monotherapyCOMBINATION_PRODUCTPatients will receive AZD4512 as monotherapy via intravenous infusion. AZD4512 is an antibody-drug conjugate targeting CD22
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

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' defin...

Countries:United StatesAustraliaCanadaChinaJapanSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07109219primaryCompletionDate: changed
LOWMay 24, 2026NCT07109219studyFirstPostDate: changed