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Also known as Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265])
Actinium zadavotide guraxetan · 1 trial · 1 indication
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.
OS is defined as the length of time from randomisation until the date of death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Actinium (225Ac) zadavotide guraxetan (AZD2265 \[FPI-2265\]) |
| Arm B | ACTIVE_COMPARATOR | Investigator's choice of cabazitaxel, ARPI, or radium-223 |
| Name | Type | Description |
|---|---|---|
| Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]) | DRUG | IV |
| Cabazitaxel | DRUG | IV in combination with oral prednisone/prednisolone |
| Abiraterone | DRUG | Oral in combination with prednisone/prednisolone |
| Enzalutamide | DRUG | Oral |
| Apalutamide | DRUG | Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026) |
| Darolutamide | DRUG | Oral; Available only to participants randomized under Protocol Version 2.0; not offered to participants randomized under Protocol Version 3.0 (04 June 2026) |
| Deutenzalutamide | DRUG | Oral; available in China only |
| Radium-223 | DRUG | IV |
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 ...
Actinium zadavotide guraxetan is being developed for metastatic castration-resistant prostate cancer, specifically in patients whose tumors are PSMA-positive. It is an oncology candidate in Phase 3 testing and is not yet available as a marketed treatment.
AstraZeneca PLC (ticker AZN) is developing Actinium zadavotide guraxetan. The company is running the Phase 3 VECTRA-01 study of the agent in PSMA-positive metastatic castration-resistant prostate cancer.
Actinium zadavotide guraxetan is in Phase 3 clinical development. It is an investigational agent and has not completed the pivotal testing needed for regulatory review. Its only registered trial, VECTRA-01, is currently recruiting participants.
Actinium zadavotide guraxetan is being studied in the Phase 3 VECTRA-01 trial, NCT07611110, which compares AZD2265 with standard of care in PSMA-positive metastatic castration-resistant prostate cancer. The trial is recruiting 670 male participants aged 18 and older across sites in the United States, Europe, Asia, Latin America, and Australia.
Yes. Actinium zadavotide guraxetan is also known as Actinium (225Ac) zadavotide guraxetan, AZD2265, and FPI-2265. These names refer to the same AstraZeneca development candidate, and AZD2265 is the designation used in the VECTRA-01 trial title.
VECTRA-01, NCT07611110, is a randomized, active-controlled Phase 3 trial with planned enrollment of 670 patients. It enrolls male participants aged 18 years and older with PSMA-positive metastatic castration-resistant prostate cancer and is recruiting across 25 countries, including the United States, United Kingdom, Germany, Japan, China, and Brazil.