Actively Recruiting
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)
Led by Novartis Pharmaceuticals · Updated on 2026-06-03
123
Participants Needed
18
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMO959 combined with lutetium (177Lu) vipivotide tetraxetan (AAA617) and an androgen receptor pathway inhibitor (ARPI) in adult men with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI treatment. This phase Ib/II study focuses on participants who may or may not have prior taxane chemotherapy exposure, aiming to explore new treatment options for this patient population. The study consists of two phases: Phase Ib includes dose escalation cohorts to establish the recommended dose of AMO959 when combined with AAA617 and ARPI (abiraterone or enzalutamide). Initially, AMO959 is given alone, then combined with AAA617. Phase II randomizes participants into three groups receiving different combinations of AMO959, AAA617, and ARPI at the recommended dose levels. Treatments are administered in cycles every six weeks for up to six cycles, with varying schedules of AMO959 and AAA617 dosing as described for each group. Participants will be closely monitored throughout the study for safety, adverse events, dose adjustments, and treatment exposure lasting up to 24 to 45 months depending on phase. Researchers will assess biochemical responses, progression-free survival, overall response, and quality of life measures. Blood samples will be collected to measure drug levels and radiation doses, and imaging scans will be used to evaluate disease progression. The total participation duration may extend up to several years with ongoing safety and efficacy evaluations.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent prior to study participation
- Male adults 18 years of age or older
- ECOG performance status of 0 to 2
- Histologically confirmed adenocarcinoma of the prostate
- For Phase Ib: Prior exposure to up to one line of taxane-based chemotherapy allowed
- For Phase II: No prior taxane chemotherapy in mCRPC setting (allowed in mHSPC setting)
- PSMA-PET positive disease confirmed by approved imaging agent
- Castration level of testosterone (< 50 ng/dL) and/or use of androgen deprivation therapy
- Diagnosis of metastatic castration resistant prostate cancer with documented progression on one prior ARPI treatment
You will not qualify if you...
- Concurrent local or systemic antineoplastic treatments within 28 days before enrollment or randomization
- Prior treatment with any radioligand therapy (RLT) or PSMA-targeted agents
- Use of any other investigational agents within 28 days prior to first study treatment dose
- Serious medical conditions that might interfere with study participation or follow-up
- History of CNS metastases unless treated and neurologically stable without corticosteroids for neurological integrity
- Participants with histology other than adenocarcinoma (e.g., neuroendocrine or intraductal subtypes)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive initial dosing of AMO959 alone before combination treatments begin.
Multiple visits during initial dosing period
Duration - Up to approximately 36 weeks (6 cycles of 6 weeks each)
Participants receive AMO959 combined with AAA617 and an androgen receptor pathway inhibitor (ARPI) or variations thereof, repeated every 6 weeks for up to 6 cycles.
Visits every 6 weeks for up to 6 cycles
Duration - Up to approximately 45 months
Participants are monitored for safety, adverse events, and treatment response after completion of treatment cycles.
Periodic visits for safety and assessment
Trial Site Locations
Total: 18 locations
1
Rio Grande Urology
El Paso, Texas, United States, 79912
Actively Recruiting
2
Utah Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
3
Novartis Investigative Site
Malvern, Victoria, Australia, 3144
Actively Recruiting
4
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Actively Recruiting
5
Novartis Investigative Site
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
6
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
7
Novartis Investigative Site
Clermont-Ferrand, France, 63011
Actively Recruiting
8
Novartis Investigative Site
Nantes, France, 44093
Actively Recruiting
9
Novartis Investigative Site
Villejuif, France, 94800
Actively Recruiting
10
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
11
Novartis Investigative Site
München, Germany, 80377
Actively Recruiting
12
Novartis Investigative Site
Cona, FE, Italy, 44124
Actively Recruiting
13
Novartis Investigative Site
Milan, MI, Italy, 20133
Actively Recruiting
14
Novartis Investigative Site
Naples, Italy, 80131
Actively Recruiting
15
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
16
Novartis Investigative Site
Granada, Andalusia, Spain, 18014
Actively Recruiting
17
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
18
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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