Actively 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
Led by Novartis Pharmaceuticals · Updated on 2026-05-11
123
Participants Needed
12
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 participation
- Adults 18 years of age or older
- ECOG performance status of 0 to 2
- Histologically confirmed adenocarcinoma of the prostate
- Phase Ib: Prior exposure to up to 1 line of taxane-based chemotherapy allowed
- Phase II: No prior taxane chemotherapy in mCRPC setting (allowed in mHSPC setting)
- PSMA-PET positive disease confirmed by approved imaging and central reading
- Castration level of testosterone (< 50 ng/dL) or use of concomitant ADT
- Diagnosed with mCRPC with documented progressive disease while on ARPI treatment in mHSPC or earlier setting
- Progression defined by PSA increases, soft-tissue progression, or bone disease progression according to specified criteria
You will not qualify if you...
- Concurrent local or systemic antineoplastic treatments within 28 days prior to enrollment or randomization
- Prior treatment with any radioligand therapy (RLT) or PSMA-targeted agents
- Use of other investigational agents within 28 days before first study treatment dose
- Serious medical conditions interfering with study procedures or follow-up
- History of CNS metastases unless treated and neurologically stable without corticosteroids for neurologic maintenance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 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
Clermont-Ferrand, France, 63011
Actively Recruiting
7
Novartis Investigative Site
Nantes, France, 44093
Actively Recruiting
8
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
9
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
10
Novartis Investigative Site
Granada, Andalusia, Spain, 18014
Actively Recruiting
11
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
12
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
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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