A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT ID: NCT07047118
Last Updated: 2026-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2025-07-03
2028-11-04
Brief Summary
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Detailed Description
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JSB462 administration starts at day 1 of randomization, whereas AAA617 administration starts at day 1 of treatment period. Participants in arm 1 and arm 2 will therefore receive JSB462 during the 14-day randomization period before first administration of AAA617.
* JSB462 is administered orally, daily and continuously (100 mg or 300 mg once a day (QD)) until disease progression per Prostate Cancer Working Group (PCWG) 3-modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
* AAA617 will be administered at 7.4 gigabecquerel (GBq) intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
During the post-treatment follow up period:
* Safety follow-Up: After discontinuation of study treatment, all participants will be followed for at least 1 safety follow-up visit (30 days \[+/- 7 days\] after end of treatment visit). Subsequent lines of therapy may be administered according to investigator's discretion after treatment discontinuation.
* Long-term follow-up: Starts after the Safety follow-up period and lasts until the end of study. Safety, efficacy and survival information may be collected from the participants during this period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
JSB462 100 mg QD + AAA617 7.4 GBq Q6W
JSB462
Administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
AAA617
administered at 7.4 GBq intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
Arm 2
JSB462 300 mg QD + AAA617 7.4 GBq Q6W
JSB462
Administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
AAA617
administered at 7.4 GBq intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
Arm 3
AAA617 7.4 GBq Q6W
AAA617
administered at 7.4 GBq intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
Interventions
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JSB462
Administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
AAA617
administered at 7.4 GBq intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Prior treatment with a protein degrader compound that targets AR is not allowed
18 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Cancer And Blood Spclsts of AZ
Casa Grande, Arizona, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Indiana University
Indianapolis, Indiana, United States
XCancer Omaha LLC
Omaha, Nebraska, United States
NYU Laura and Isaac Perlmutter Cancer Center
New York, New York, United States
Univ of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology San Antonio
San Antonio, Texas, United States
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
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Melbourne, Victoria, Australia
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Linz, , Austria
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Vienna, , Austria
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Montreal, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Olomouc, , Czechia
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Prague, , Czechia
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Brest, , France
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Marseille, , France
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Tours, , France
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Essen, , Germany
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Rostock, , Germany
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Afula, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Genova, GE, Italy
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Roma, RM, Italy
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Nijmegen, Gerlderland, Netherlands
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Leeuwarden, Provincie Friesland, Netherlands
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Hoofddorp, , Netherlands
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Singapore, , Singapore
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Seoul, , South Korea
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Seoul, , South Korea
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Granada, Andalusia, Spain
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El Palmar, Murcia, Spain
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Barcelona, , Spain
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Seville, , Spain
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Taipei, , Taiwan
Novartis Investigative Site
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-520155-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CJSB462B12201
Identifier Type: -
Identifier Source: org_study_id
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