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

Source: https://onco.cc/trials/nct06894511/  
OnCo record `nct06894511` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of FAP-2286, Lutetium-177 vipivotide tetraxetan in prostate cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.

## Summary

An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC is a phase 2 interventional study registered as NCT06894511 by Novartis Pharmaceuticals, with 7 participants enrolled, started 2025-09-11 and due to reach its primary completion in 2026-10-15. Interventions recorded: AAA617, ARPI: Abiraterone, ARPI: Enzalutamide. Conditions listed: Metastatic Castration Resistant Prostate Cancer (mCRPC). No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT06894511
- Phase: 2
- Setting: 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)
- Sponsor: Novartis Pharmaceuticals
- Enrolled: 7

## Sources

- ClinicalTrials.gov NCT06894511: https://clinicaltrials.gov/study/NCT06894511

## Connected records

- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- drugs: [FAP-2286 (177Lu / 68Ga)](https://onco.cc/drugs/fap-2286/), [Lutetium-177 vipivotide tetraxetan](https://onco.cc/drugs/pluvicto/)
- companies: [Novartis](https://onco.cc/companies/novartis/)

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