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AZD4512 monotherapy

Phase 1

B-cell Acute Lymphoblastic Leukemia (B-ALL) | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jul 13, 2026

Target and mechanism

ModalitySmall molecule

Also known as AZD4512

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED

Total Trials1

Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

AZD4512 monotherapy · 1 trial · 1 indication

Phase 1 1

NCT07109219Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic LeukemiaB-cell Acute Lymphoblastic Leukemia (B-ALL)

RECRUITING83 Analytics

PHASE1RECRUITING

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

B-cell Acute Lymphoblastic Leukemia (B-ALL)

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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

Arm	Type	Description
Module 1 Dose Escalation	EXPERIMENTAL	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.
Module 2 Dose Optimization	EXPERIMENTAL	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

Name	Type	Description
AZD4512 monotherapy	COMBINATION_PRODUCT	Patients 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 to 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)

LOWJul 13, 2026NCT07109219lastUpdatePostDate: changed

LOWJul 13, 2026NCT07109219lastUpdatePostDate: changed

LOWJun 11, 2026NCT07109219lastUpdatePostDate: changed

LOWJun 11, 2026NCT07109219lastUpdatePostDate: changed

Frequently asked questions about AZD4512 monotherapy

What is AZD4512 used for?

AZD4512 is an investigational small molecule being studied for B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma. It is being evaluated as a monotherapy or in combination with other anticancer agents in clinical trials.

Who makes AZD4512?

AZD4512 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN.

What phase is AZD4512 in?

AZD4512 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials are currently recruiting participants.

What clinical trials is AZD4512 in?

AZD4512 is being studied in two recruiting trials: NCT07109219 for B-cell Acute Lymphoblastic Leukemia and NCT07123454 for relapsed/refractory B-cell Non-Hodgkin Lymphoma. Both are Phase 1 studies evaluating AZD4512 as monotherapy or in combination with other anticancer agents.

Is AZD4512 the same as AZD4512 monotherapy?

Yes, AZD4512 monotherapy refers to the same drug, AZD4512, when given alone. The clinical trials also study AZD4512 in combination with other anticancer agents.