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AZD4512

Phase 1

B-cell Non-Hodgkin Lymphoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 28, 2026

Target and mechanism

ModalitySmall molecule

Also known as AZD4512 monotherapy

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment91

FDA Designations

No designations recorded

Clinical trial landscape

AZD4512 · 1 trial · 1 indication

Phase 1 1
NCT07123454A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin LymphomaB-cell Non-Hodgkin Lymphoma
RECRUITING91 Analytics
PHASE1RECRUITING
A Phase I/II Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
B-cell Non-Hodgkin LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants with dose-limiting toxicities (DLTs)
Up to 4 weeks

To identify the maximum tolerated dose (MTD) and/or doses of AZD4512 for subsequent evaluation in participants with R/R B-NHL

Frequency, duration, severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) and Serious Adverse Events (SAEs)
From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy

To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL

Frequency of SAEs/AEs leading to discontinuation of AZD4512
From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy

To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL

Number of participants with clinically significant alterations in vitals signs and abnormal laboratory parameters
From the first dose up to and including 30 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy

To assess the safety and tolerability of AZD4512 in participants with R/R B-NHL

Secondary Endpoints

Objective response rate (ORR)
Up to 2 years
Complete response (CR) rate
Up to 2 years
Duration of response (DoR)
Up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Module 1: AZD4512 Monotherapy dose escalation + backfillEXPERIMENTALIn Mod 1, the efficacy and safety of AZD4512 will be evaluated in R/R B-NHL. Module 1 will consist of both dose escalation and Pharmacodynamic/safety backfills which may be used to support MTD and/or Optimal biological dose (OBD)

Interventions

NameTypeDescription
AZD4512DRUGAZD4512 is an antibody-drug conjugate targeting cluster of differentiation 22 (CD22) that will be administered via IV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Key Inclusion Criteria: * Eligible patients must be adults (≥18 years) * Documented histologically confirmed diagnosis of B-cell non-Hodgkin lymphoma (B-NHL) as per World Health Organization (WHO) 2022 classification. In the dose escalation phase, any B-NHL subtype is allowed (excluding some subtyp...

Countries:United StatesAustraliaChinaItalyJapanSouth KoreaTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT07123454lastUpdatePostDate: changed
LOWAug 28, 2026NCT07123454lastUpdatePostDate: changed
LOWJun 29, 2026NCT07123454lastUpdatePostDate: changed
LOWJun 29, 2026NCT07123454lastUpdatePostDate: changed

Frequently asked questions about AZD4512

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.