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
Start Date
12/5/2025
Completion Date
9/13/2029
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.
Detailed Description
This study will consist of two phases: 1. The escalation phase (Ib) will consist of provisionally three dose level cohorts of 3-6 participants investigating the safety, tolerability, and to determine the recommended dose for expansion (RDE) of AMO959 with standard dose of AAA617 +/- ARPI (abiraterone or enzalutamide). Initially AMO959 monotherapy will be administered, and then AMO959 will be given along with AAA617 in the same participants. Dose escalation meetings (DEMs) will occur when all participants in a dose level cohort have completed the DLT evaluation period or have experienced a DLT prior to the end of the evaluation period. 2. The Phase II will follow with 25 participants per arm randomized in a 1:1:1 ratio treated at the RDE(s) of AMO959 along with AAA617 and ARPI (abiraterone or enzalutamide) and AAA617 and ARPI (abiraterone or enzalutamide).
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
AMO959
AAA617
Enzalutamide
Abiraterone
Conditions
Locations
VA Greater LA Healthcare System
Los Angeles, California 90073
United States
Rio Grande Urology
El Paso, Texas 79912
United States
Utah Intermountain Medical Center
Murray, Utah 84107
United States
Novartis Investigative Site
Malvern, Victoria 3144
Australia
Novartis Investigative Site
Melbourne, Victoria 3004
Australia
Novartis Investigative Site
Murdoch, Western Australia 6150
Australia
Novartis Investigative Site
Bordeaux, 33076
France
Novartis Investigative Site
Clermont-Ferrand, 63011
France
Novartis Investigative Site
Nantes, 44093
France
Novartis Investigative Site
Villejuif, 94800
France
Novartis Investigative Site
Dresden, Saxony 01307
Germany
Novartis Investigative Site
Essen, 45147
Germany
Novartis Investigative Site
München, 80377
Germany
Novartis Investigative Site
Cona, FE 44124
Italy
Novartis Investigative Site
Milan, MI 20133
Italy
Novartis Investigative Site
Naples, 80131
Italy
Novartis Investigative Site
Sapporo, Hokkaido 060-8648
Japan
Novartis Investigative Site
Granada, Andalusia 18014
Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona 08907
Spain
Novartis Investigative Site
Barcelona, 08036
Spain
Novartis Investigative Site
Madrid, 28041
Spain