Clinical Trial · NCT07611110

AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

Overview

The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.

Sponsor

AstraZeneca

Phase

Phase 3

Contacts

AstraZeneca Clinical Study Information Center (CONTACT)

information.center@astrazeneca.com

1-877-240-9479

ClinicalTrials.gov

NCT07611110

Drug / Compound

AZD2265

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

Diagnosis of adenocarcinoma of prostate.
Must have had prior orchiectomy and/or ongoing ADT and a castrate level of plasma/serum testosterone.
Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.
Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and/or non-measurable) that is suitable for repeated assessment by CT and/or MRI and/or bone scan.
* ≥ 18 years of age.

Exclusion

* Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).
Receipt of \> 6 cycles of PSMA-directed β-emitting therapeutic RC.
Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.
History of another primary malignancy, with exceptions.
Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.