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Study identifier: NCT07226986 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 1/Phase 2
Planned participants123
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals  ·  1-888-669-6682  ·  novartis.email@novartis.com

Novartis Pharmaceuticals  ·  +41613241111  ·  novartis.email@novartis.com

Always discuss trial participation with your own doctor first.

Locations (21)

VA Greater LA Healthcare SystemLos Angeles, California, United StatesRecruiting
Rio Grande UrologyEl Paso, Texas, United StatesRecruiting
Utah Intermountain Medical CenterMurray, Utah, United StatesRecruiting
Novartis Investigative SiteMalvern, Victoria, AustraliaRecruiting
Novartis Investigative SiteMelbourne, Victoria, AustraliaRecruiting
Novartis Investigative SiteMurdoch, Western Australia, AustraliaRecruiting
Novartis Investigative SiteBordeaux, FranceRecruiting
Novartis Investigative SiteClermont-Ferrand, FranceRecruiting
Novartis Investigative SiteNantes, FranceRecruiting
Novartis Investigative SiteVillejuif, FranceRecruiting
Novartis Investigative SiteDresden, Saxony, GermanyRecruiting
Novartis Investigative SiteEssen, GermanyRecruiting

+ 9 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07226986