RecruitingPhase 1Phase 2NCT07226986

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

A Phase Ib/II Open-label, Multi-center Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With an Androgen Receptor Pathway Inhibitor (ARPI) in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)


Sponsor

Novartis Pharmaceuticals

Enrollment

123 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug combination — AMO959 with a radioactive therapy called lutetium-177 PSMA (which targets prostate-specific membrane antigen) plus a hormone-blocking drug — in men with advanced prostate cancer that no longer responds to hormone therapy and shows PSMA on scans. **You may be eligible if...** - You are 18 or older with confirmed prostate adenocarcinoma - Your cancer has spread and no longer responds to hormone therapy (metastatic castration-resistant) - A PSMA scan shows your cancer is PSMA-positive - Your testosterone levels are very low (under 50 ng/dL) - You have progressed on one hormone-blocking therapy (ARPI) and did not progress on more than one - Your general health is good (ECOG 0-2) **You may NOT be eligible if...** - Your cancer is of a different cell type (e.g., neuroendocrine) - You have already received chemotherapy for metastatic castration-resistant prostate cancer (for Phase 2) - Your PSMA scan is negative Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAMO959

DNA Damage Response inhibitor

RADIATIONAAA617

PSMA-targeted radiopharmaceutical

DRUGEnzalutamide

Androgen receptor pathway inhibitor

DRUGAbiraterone

Androgen receptor pathway inhibitor


Locations(11)

Rio Grande Urology

El Paso, Texas, United States

Novartis Investigative Site

Malvern, Victoria, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Murdoch, Western Australia, Australia

Novartis Investigative Site

Clermont-Ferrand, France

Novartis Investigative Site

Nantes, France

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Granada, Andalusia, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07226986