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AZD4045

Phase 1

Relapsed or Refractory Multiple Myeloma | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Aug 27, 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

Clinical trial landscape

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 221 trials (matched to "Relapsed or Refractory Multiple Myeloma")

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Recent Changes (Last 90 Days)

MEDIUMAug 27, 2026NCT07681596Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMAug 27, 2026NCT07681596Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 2, 2026NCT07681596NEW_TRIAL: changed
LOWJul 2, 2026NCT07681596NEW_TRIAL: changed

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.