drugset / Trial / NCT06881823

Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC

NCT06881823

Phase 1/2 Withdrawn Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to learn more about the effects of AAA602 and AAA802 in men with prostate-specific membrane antigen (PSMA) positive high-risk localized prostate cancer (HRLPC) before surgery to remove the prostate and lymph nodes present in the pelvis area. Lymph nodes are small structures near the prostate that help fight infections. These lymph nodes are removed during surgery because they are a site the disease can spread to.

Timeline

Start
2026-06-29
Primary completion
2030-03-31
Completion
2033-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator AAA602 Unknown Intravenous
Comparator AAA802 Unknown Intravenous
Comparator 18F-DCFPyL Diagnostic / imaging agent
Comparator 18F-PSMA-1007 Diagnostic / imaging agent
Comparator 68Ga-PSMA-11 Diagnostic / imaging agent Other
Comparator FLOTUFOLASTAT Diagnostic / imaging agent

Indications