OncRef

Clinical Trial: NCT06894511

An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Novartis Pharmaceuticals
Information Provided By:Novartis
Last Update Posted:2026-10-21

Study Overview

Brief Summary

The purpose of this study is to assess safety of combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI and AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the metastic castrate resistant prostate cancer (mCRPC) setting.

Official Title

A Phase II, Open-label, Multi-Center, Randomized Study of Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC)

Intervention / Treatment

  • Drug: AAA617
  • Drug: ARPI: Abiraterone
  • Drug: ARPI: Enzalutamide

Other Study ID Numbers

  • CAAA617B1US01

Start Date (Actual)

2025-09-11

Primary Completion Date (Estimated)

2026-10-15

Study Completion Date (Estimated)

2026-10-15

Enrollment (Actual)

7

Study Type

Interventional

Phase

Phase 2