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AZD4045

Phase 1

Relapsed or Refractory Multiple Myeloma | Monoclonal antibody | Oncology |AstraZeneca PLC|Trials Updated: Oct 15, 2026

AZD4045 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment101

FDA Designations

No designations recorded

AZD4045 clinical trials

AZD4045 · 1 trial · 1 indication

Phase 1 1
NCT07681596A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple MyelomaRelapsed or Refractory Multiple Myeloma
RECRUITING101 Analytics
PHASE1RECRUITING
A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events (AEs) and serious AEs (SAEs)
Through study completion, an average of 2 years

Incidence and severity of adverse events (AEs) and serious AEs (SAEs)

Dose-limiting toxicities (DLT)
28 days

Incidence and severity of dose-limiting toxicity (DLT) events

Secondary Endpoints

Efficacy - Objective Response Rate (ORR)
Through study completion, an average of 2 years
Efficacy - Complete Response Rate (CRR)
Through study completion, an average of 2 years
Efficacy - Duration of Response (DOR)
Through study completion, an average of 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Module 1: AZD4045 monotherapyEXPERIMENTAL -
Module 1: AZD4045 in association with daratumumab and aldesleukinEXPERIMENTAL -

Interventions

NameTypeDescription
AZD4045BIOLOGICALAllogeneic Chimeric Antigen Receptor T cell (CAR-T) Therapy Targeting B Cell Maturation Antigen (BCMA)
DaratumumabDRUGAnti-CD38 monoclonal antibody
AldesleukinDRUGRecombinant human IL-2
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Participant must be 18 years or older at the time of signing the informed consent form. * Participants must have documented diagnosis of MM according to the IMWG diagnostic criteria. * Participant must have one or more of the following measurable disease criteria: * Serum M...

Countries:United StatesAustralia
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Competitive Landscape -Multiple Myeloma 338 trials (matched to "Relapsed or Refractory Multiple Myeloma")

Recent Changes (Last 90 Days)

LOWOct 15, 2026NCT07681596lastUpdatePostDate: changed
LOWOct 15, 2026NCT07681596lastUpdatePostDate: changed
MEDIUMAug 27, 2026NCT07681596Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMAug 27, 2026NCT07681596Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about AZD4045

What is AZD4045 used for?

AZD4045 is an investigational monoclonal antibody being developed for the treatment of relapsed or refractory multiple myeloma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing AZD4045?

AZD4045 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for relapsed or refractory multiple myeloma.

What phase is AZD4045 in?

AZD4045 is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of relapsed or refractory multiple myeloma, and it has not yet been approved for commercial use.

What clinical trials is AZD4045 in?

AZD4045 is being evaluated in a Phase 1 clinical trial with the identifier NCT07681596. This trial is a modular, multicenter study enrolling approximately 101 participants with relapsed or refractory multiple myeloma. The study is currently recruiting participants in the United States and Australia.

Is AZD4045 being studied in a randomized trial?

AZD4045 is being studied in a controlled clinical trial, but the trial is not randomized and is not double-blind. The Phase 1 study NCT07681596 is an open-label, controlled trial enrolling participants with relapsed or refractory multiple myeloma.