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
- Diseases
- Prostate cancer
- 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
Sites (44)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Active, not recruiting |
| Ordensklinikum Linz GmbH Coordinator of this site? Confirm its status | Linz | Austria | Active, not recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Burnaby | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Active, not recruiting |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Active, not recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Active, not recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Spaarne Gasthuis Stichting Coordinator of this site? Confirm its status | Hoofddorp | Netherlands | Active, not recruiting |
| Canisius Wilhelmina Ziekenhuis Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| - Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Rocky Mountain Cancer Centers Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| City of Hope National Medical Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| NYU Laura and Isaac Perlmutter Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| XCancer Omaha LLC Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Univ of Pittsburgh Cancer Institute Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Urology San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Providence Saint Johns Health Ctr Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.