An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
NCT ID: NCT06991556
Last Updated: 2026-02-04
Study Results
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Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2025-07-07
2035-11-07
Brief Summary
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An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)
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Detailed Description
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During the treatment period:
* JSB462 is administered from randomization, orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
* Abiraterone 1000 mg or enzalutamide 160 mg are administered from randomization, orally, daily, and continuously until disease progression per PCWG3-modified RECIST 1.1 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 treatment discontinuation). 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 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 + abiraterone 1000 mg QD
JSB462
JSB462 is administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Abiraterone
Abiraterone 1000 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Arm 2
JSB462 300 mg QD + abiraterone 1000 mg QD
JSB462
JSB462 is administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Abiraterone
Abiraterone 1000 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Arm 3
abiraterone 1000 mg QD or enzalutamide 160 mg QD
Abiraterone
Abiraterone 1000 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Enzalutamide
Enzalutamide 160 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Interventions
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JSB462
JSB462 is administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Abiraterone
Abiraterone 1000 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision.
Enzalutamide
Enzalutamide 160 mg is administered orally, daily and continuously until disease progression per PCWG3-modified RECIST 1.1 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
* Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible
* High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non-nodal lesion and/or ≥4 metastatic bone lesions (with at least one lesion outside the vertebral column and/or pelvis) in imaging exams (CT/MRI or bone scan) according to local radiology assessment by the investigator obtained ≤28 days prior to randomization
* Participants must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Ongoing ADT (as defined by prior orchiectomy and/or ongoing GnRH analog/antagonist) for ≤90 days is allowed prior to randomization, provided that PSA zero (PSA level \<0.2 ng/ml according to local laboratory as assessed by the investigator) is not achieved prior to randomization.
Exclusion Criteria
* Participants with biochemical recurrence only or those without evidence of metastatic disease by radiological imaging (CT/MRI or bone scan) are not eligible
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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University of California San Diego - Moores Cancer Center
La Jolla, California, United States
Saint Johns Cancer Institute
Santa Monica, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, United States
Mass General Hospital
Boston, Massachusetts, United States
XCancer Omaha LLC
Omaha, Nebraska, United States
Perlmutter Cancer Centre
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Urology San Antonio
San Antonio, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Fred Hutch Cancer Research
Seattle, Washington, United States
Novartis Investigative Site
Adelaide, South Australia, Australia
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Clayton, Victoria, Australia
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
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Beijing, Chaoyang, China
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Beijing, , China
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Brno, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Nice, Alpes Maritimes, France
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Marseille, , France
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Quint-Fonsegrives, , France
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Suresnes, , France
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Hamburg, , Germany
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Lübeck, , Germany
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Nürtingen, , Germany
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Asti, AT, Italy
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Trento, TN, Italy
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Verona, VR, Italy
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Zwolle, Overijssel, Netherlands
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Dordrecht, South Holland, Netherlands
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Hoofddorp, , Netherlands
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Schiedam, , Netherlands
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Kielce, , Poland
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Olsztyn, , Poland
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Oświęcim, , Poland
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Skorzewo, , Poland
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Seoul, Korea, South Korea
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Seoul, , South Korea
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Santander, Cantabria, Spain
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Badajoz, Extremadura, Spain
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Lugo, Galicia, Spain
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Pamplona, Navarre, Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Kaohsiung City, , Taiwan
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Tainan, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-520156-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CJSB462C12201
Identifier Type: -
Identifier Source: org_study_id
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