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AZD0305

Phase 1

Multiple Myeloma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 19, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment226

FDA Designations

No designations recorded

Clinical trial landscape

AZD0305 · 1 trial · 1 indication

Phase 1 1
NCT06106945AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple MyelomaMultiple Myeloma
RECRUITING226 Analytics
PHASE1RECRUITING
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)
From first dose of AZD0305 until the end of Cycle 1. Cycle 1 (the DLT assessment period is 21 days for Module 1 Group A and 28 days for Module 1 Group B, Module 2, and Module 3)

A DLT is any toxicity occuring from the first dose of AZD0305 up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes, any death not clearly due to the underlying disease or extraneous causes, pre-defined haematological and non-haematological toxicities

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
From time of Informed consent to 30 days post end of treatment

Number of patients with adverse events and serious adverse events by system organ class and preferred term

Frequency of dose modifications, dose delays, and treatment discontinuations due to AEs (Module 2 and Module 3)
From first dose of study treatment until End of treatment (EOT), assessed up to approximately 2 years (each cycle is 28 days)

Number and percentage of participants with dose modifications, dose delays, and permanent discontinuations due to adverse events (for AZD0305 and combination agent\[s\], as applicable), per protocol-defined dose modification rules.

Secondary Endpoints

Phase Ia: Objective Response Rate (ORR)
From first dose of AZD0305 to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
Phase Ia: Duration of response (DoR)
From the first documented response to confirmed progressive disease or death (approximately 2 years)
Phase Ia: Progression free Survival (PFS)
From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD0305 monotherapyEXPERIMENTALModule 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be administered at specified dose levels.
AZD0305 + ElranatamabEXPERIMENTALModule2: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with elranatamab, following the module-specific dosing.
AZD0305 + Pomalidomide and DexamethasoneEXPERIMENTALModule3: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with pomalidomide and dexamethasone, following the module-specific dosing.

Interventions

NameTypeDescription
AZD0305DRUGAZD0305 Investigational product
ElranatamabDRUGModule 2 Investigational product
PomalidomideDRUGModule 3 Standard of Care (background treatment)
DexamethasoneDRUGModule 3 Standard of Care (background treatment)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites43

Key Inclusion Criteria: * Participants must be at least 18 years of age or the legal age of consent in the jurisdiction * in which the study is taking place; * Eastern Cooperative Oncology Group performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3; * Documentation of Multiple Myeloma...

Countries:United StatesAustraliaBrazilCanadaChinaFranceGermanyJapanSpain
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Competitive Landscape -Multiple Myeloma 221 trials

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)

LOWAug 20, 2026NCT06106945lastUpdatePostDate: changed
LOWAug 20, 2026NCT06106945lastUpdatePostDate: changed
LOWAug 20, 2026NCT06106945lastUpdatePostDate: changed
LOWAug 20, 2026NCT06106945lastUpdatePostDate: changed
LOWJul 13, 2026NCT06106945lastUpdatePostDate: changed
LOWJul 13, 2026NCT06106945lastUpdatePostDate: changed

Frequently asked questions about AZD0305

What is AZD0305 used for in multiple myeloma?

AZD0305 is an investigational small molecule being studied for the treatment of multiple myeloma. It is currently in Phase 1 clinical development as a monotherapy or in combination with other anticancer agents for participants with this blood cancer. The drug is not yet approved and remains under investigation.

Who is developing AZD0305?

AZD0305 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with multiple myeloma.

What phase is AZD0305 in?

AZD0305 is currently in Phase 1 clinical development. This early-stage trial is designed to assess the drug's safety, tolerability, and preliminary activity in participants with multiple myeloma. As an investigational agent, it has not yet received regulatory approval and is still undergoing clinical evaluation.

What clinical trials is AZD0305 in?

AZD0305 is being evaluated in a Phase 1 clinical trial registered as NCT06106945. This study is recruiting participants with multiple myeloma and is being conducted across multiple countries, including the United States, Australia, Brazil, Canada, China, France, Germany, Japan, and Spain. The trial aims to enroll 226 participants.

How does AZD0305 work?

AZD0305 is a small molecule therapeutic agent. Its specific molecular target has not been disclosed in the available information, so its precise mechanism of action in treating multiple myeloma is not detailed. The drug is being investigated for its potential to combat this cancer when used alone or with other treatments.