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Actinium zadavotide guraxetan

Phase 3

Metastatic Castration-resistant Prostate Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Aug 26, 2026

Target and mechanism

ModalitySmall molecule

Also known as Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment670

FDA Designations

No designations recorded

Clinical trial landscape

Actinium zadavotide guraxetan · 1 trial · 1 indication

Phase 3 1
NCT07611110AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)Metastatic Castration-resistant Prostate Cancer
RECRUITING670 Analytics
PHASE3RECRUITING
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
Metastatic Castration-resistant Prostate Cancer
NCT07611110670
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Study Endpoints

Primary Endpoints

Radiographic Progression-Free Survival (rPFS)
From randomization until first radiographic progression per RECIST 1.1/PCWG3 by BICR, or death from any cause, whichever occurs first (up to approximately 33 months)

rPFS is defined as the time from randomisation to radiographic progression, as assessed by the BICR per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or death due to any cause.

Overall Survival (OS)
From randomization until death from any cause (up to approximately 33 months)

OS is defined as the length of time from randomisation until the date of death due to any cause.

Secondary Endpoints

Progression-Free Survival (PFS)
From randomization until first documented progression (radiographic, clinical, or PSA progression) or death in the absence of progression, whichever occurs first (up to approximately 33 months)
Assessment of PSA50 (≥50% prostate-specific antigen reduction)
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
Assessment of PSA90 (≥90% prostate-specific antigen reduction)
From C1D1, assessed each treatment cycle then every 8 weeks after EOT until BICR-assessed radiographic progression per RECIST 1.1/PCWG3 (up to approximately 33 months)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALActinium (225Ac) zadavotide guraxetan (AZD2265 \[FPI-2265\])
Arm BACTIVE_COMPARATORInvestigator's choice of cabazitaxel, ARPI, or radium-223

Interventions

NameTypeDescription
Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])DRUGIV
CabazitaxelDRUGIV in combination with oral prednisone/prednisolone
AbirateroneDRUGOral in combination with prednisone/prednisolone
EnzalutamideDRUGOral
ApalutamideDRUGOral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)
DarolutamideDRUGOral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026)
DeutenzalutamideDRUGOral; available in China only
Radium-223DRUGIV
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites132

Inclusion Criteria: * ≥ 18 years of age. * Diagnosis of adenocarcinoma of prostate. * Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone. * Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic ...

Countries:United StatesAustraliaAustriaBrazilCanadaChinaFinlandFranceGermanyIndiaIsraelJapanPolandSouth KoreaSpainSwedenTaiwanThailandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)

MEDIUMAug 26, 2026NCT07611110primaryCompletionDate: changed
MEDIUMAug 26, 2026NCT07611110primaryCompletionDate: changed
LOWJul 2, 2026NCT07611110lastUpdatePostDate: changed
LOWJul 2, 2026NCT07611110lastUpdatePostDate: changed
LOWJul 2, 2026NCT07611110lastUpdatePostDate: changed
LOWJul 2, 2026NCT07611110lastUpdatePostDate: changed