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AZD8421

Phase 1

ER+ HER2- Advanced Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 11, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment564
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06188520A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid TumorsPHASE1 RECRUITING 564 — — Dec 5, 2023Aug 4, 2027May 11, 202614 United States, Australia +3
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Study Endpoints
Primary Endpoints
Incidence of dose limiting toxicities (DLTs) as defined in the protocol.
From start of treatment until the end of DLT period, assessed up to 28 days.

Percentage of participants with incidence of DLTs.

Incidence of AEs/SAEs
From start of treatment until the end of safety follow-up, approximately 18 months.

Percentage of participants with incidence of AEs/SAEs.

Clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs.
From start of treatment until the end of safety follow-up, approximately 18 months.

Percentage of participants with clinically significant changes from baseline in clinical laboratory parameters, vital signs and ECGs.

Discontinuation of AZD8421 due to toxicity
From start of treatment until the end of safety follow-up, approximately 18 months.

Percentage of participants that have discontinued AZD8421 due to toxicity.

Secondary Endpoints
Overall Response Rate (ORR)
8 weeks from start of treatment until end of treatment or objective disease progression, approximately 18 months.
Duration of Response (DoR)
8 weeks from start of treatment until end of treatment or objective disease progression, approximately 18 months.
Disease control rate (DCR)
24 weeks after the start of treatment.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1EXPERIMENTALAZD8421 monotherapy
Module 2AEXPERIMENTALAZD8421 with camizestrant and CDK4/6 inhibitor
Interventions
NameTypeDescription
AZD8421DRUGCDK2 inhibitor
CamizestrantDRUGSERD
RibociclibDRUGCDK4/6 inhibitor
PalbociclibDRUGCDK4/6 inhibitor
AbemaciclibDRUGCDK4/6 inhibitor
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Female participants only, aged 18 or above * Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical study is the best opti...

Countries:United StatesAustraliaSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Breast Cancer 408 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib, Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy, Imlunestrant, Tamoxifen, Anastrozole
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1, Capecitabine, Paclitaxel, Nab-paclitaxel
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib, Alpelisib, Fulvestrant, Trastuzumab, Pertuzumab
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant, PF-07220060, letrozole, abemaciclib
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib, Arm A: Gedatolisib + Palbociclib + Fulvestrant
Relay Therapeutics, Inc.RLAY2PHASE3RLY-2608, Capivasertib, Fulvestrant, Palbociclib, Ribociclib
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib, Pembrolizumab, Axatilimab
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam, Alisertib, Endocrine therapy
Immutep Ltd Sponsored ADRIMMP1PHASE2eftilagimod alpha, Paclitaxel
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06188520primaryCompletionDate: changed
LOWMay 24, 2026NCT06188520studyFirstPostDate: changed