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Cabazitaxel

Phase 3

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

Target and mechanism

Molecular targetTUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, TUBA1A
Target classInhibitor
ModalitySmall molecule

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

Cabazitaxel · 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 CancerUnlock trial analytics

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

Frequently asked questions about Cabazitaxel

What is Cabazitaxel used for in Metastatic Castration-resistant Prostate Cancer?

Cabazitaxel is a small molecule being studied for the treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC). It is currently in Phase 3 clinical development as an investigational therapy. The drug is being evaluated in patients with PSMA-positive mCRPC, a specific subtype of the disease.

What does Cabazitaxel target?

Cabazitaxel is a taxane-class chemotherapy agent that works by disrupting microtubule function, which is essential for cell division. By stabilizing microtubules, it inhibits cancer cell proliferation. This mechanism is relevant in Metastatic Castration-resistant Prostate Cancer, where it is being studied as a potential treatment option.

Who makes Cabazitaxel?

Cabazitaxel 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 drug's efficacy and safety in patients with Metastatic Castration-resistant Prostate Cancer.

What phase is Cabazitaxel in?

Cabazitaxel is currently in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to compare the drug with standard of care in patients with PSMA-positive Metastatic Castration-resistant Prostate Cancer.

What clinical trials is Cabazitaxel in?

Cabazitaxel is being evaluated in a Phase 3 clinical trial with the identifier NCT07611110, titled 'AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)'. This randomized, active-controlled trial is recruiting 670 male patients aged 18 years and older across multiple countries.

Is Cabazitaxel the same as AZD2265?

Yes, Cabazitaxel is also known as AZD2265. The Phase 3 clinical trial NCT07611110, which is evaluating the drug in Metastatic Castration-resistant Prostate Cancer, uses the name AZD2265 in its title. This alternative name is used by the developer AstraZeneca PLC for the same investigational compound.