A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC

Recruiting now · Phase 1/Phase 2

Conditions studied: PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy

In brief

The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in participants with mCRPC who have failed one prior ARPI, but who have not yet been exposed to taxane treatment.

Key facts

Study ID

NCT07226986

Run by

Novartis Pharmaceuticals

People needed

123

Starts

2025-12-05

Expected to finish

2029-09-13

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

Where it is running

• VA Greater LA Healthcare System — Los Angeles, California, United States (enrolling)
• Rio Grande Urology — El Paso, Texas, United States (enrolling)
• Utah Intermountain Medical Center — Murray, Utah, United States (enrolling)
• Novartis Investigative Site — Malvern, Victoria, Australia (enrolling)
• Novartis Investigative Site — Melbourne, Victoria, Australia (enrolling)
• Novartis Investigative Site — Murdoch, Western Australia, Australia (enrolling)
• Novartis Investigative Site — Bordeaux, France (enrolling)
• Novartis Investigative Site — Clermont-Ferrand, France (enrolling)
• Novartis Investigative Site — Nantes, France (enrolling)
• Novartis Investigative Site — Villejuif, France (enrolling)
• Novartis Investigative Site — Dresden, Saxony, Germany (enrolling)
• Novartis Investigative Site — Essen, Germany (enrolling)
• Novartis Investigative Site — München, Germany (enrolling)
• Novartis Investigative Site — Cona, FE, Italy (enrolling)
• Novartis Investigative Site — Milan, MI, Italy (enrolling)
• Novartis Investigative Site — Naples, Italy (enrolling)
• Novartis Investigative Site — Sapporo, Hokkaido, Japan (enrolling)
• Novartis Investigative Site — Granada, Andalusia, Spain (enrolling)
• Novartis Investigative Site — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
• Novartis Investigative Site — Barcelona, Spain (enrolling)
• Novartis Investigative Site — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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