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NCT07047118Active, not recruitingPhase 2

A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Lutetium (177Lu) Vipivotide Tetraxetan in Adult Male Patients With PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC)

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with metastatic Castration Resistant Prostate Cancer (mCRPC) with prior exposure to at least 1 Androgen Receptor Pathway Inhibitor (ARPI) and 0-2 taxane regimens and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and pharmacokinetic (PK) data from participants randomized in the study will be evaluated.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
138 (actual)
First submitted
20 May 2025
Start date
3 Jul 2025
Primary completion date
16 Jul 2027
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT07047118
EU CT number
2024-520155-24-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 138
  • From 3 Jul 2025 to the primary completion date, 16 Jul 2027
  • 44 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with any RLT (approved or investigational) is not allowed
  • Prior treatment with a protein degrader compound that targets AR is not allowed
    • Other protocol-defined inclusion/exclusion criteria may apply.

Who the study is looking for

  • Adult male participants with histologically and/or cytologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade ≤2.
  • At least 1 bone or visceral metastatic lesion present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to initiation of study treatment.
  • Participants must be \[68Ga\]Ga-PSMA-11 PET/CT scan positive and eligible as determined by the sponsor's central reader.
  • Participant must have prior exposure to at least one second generation ARPI in the metastatic/advanced setting.
  • Previous treatment with a maximum of 2 taxane regimens is allowed.
  • Participants eligible for PARPi and/or immune checkpoint inhibitor (per local testing and according to investigator's judgement) are eligible to participate if they have previous exposure to this(these) therapy(ies).

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaActive, not recruiting
Ordensklinikum Linz GmbH
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LinzAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
-
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AdelaideAustraliaUnknown status
-
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DarlinghurstAustraliaUnknown status
-
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MelbourneAustraliaUnknown status
-
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BurnabyCanadaUnknown status
-
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MontrealCanadaUnknown status
-
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BeijingChinaUnknown status
University Hospital Olomouc
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OlomoucCzechiaActive, not recruiting
Fakultni nemocnice v Motole
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PragueCzechiaActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyActive, not recruiting
Rostock University Medical Center
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RostockGermanyActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceActive, not recruiting
-
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AfulaIsraelUnknown status
-
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BeershebaIsraelUnknown status
-
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HaifaIsraelUnknown status
-
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JerusalemIsraelUnknown status
-
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Petah TikvaIsraelUnknown status
-
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Ramat GanIsraelUnknown status
IRCCS Ospedale Policlinico San Martino
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GenoaItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
-
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SeoulSouth KoreaUnknown status
Spaarne Gasthuis Stichting
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HoofddorpNetherlandsActive, not recruiting
Canisius Wilhelmina Ziekenhuis
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NijmegenNetherlandsActive, not recruiting
-
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SingaporeSingaporeUnknown status
-
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TaipeiTaiwanUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Rocky Mountain Cancer Centers
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DenverUnited StatesUnknown status
City of Hope National Medical
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DuarteUnited StatesUnknown status
Indiana University
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IndianapolisUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
NYU Laura and Isaac Perlmutter Cancer Center
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New YorkUnited StatesUnknown status
XCancer Omaha LLC
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OmahaUnited StatesUnknown status
Univ of Pittsburgh Cancer Institute
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PittsburghUnited StatesUnknown status
Urology San Antonio
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San AntonioUnited StatesUnknown status
Providence Saint Johns Health Ctr
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Santa MonicaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.