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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: 2025-11-12

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-07

Study Completion Date

2035-11-07

Brief Summary

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This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated

Detailed Description

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The study for each participant consists of a Screening period (28 days), a treatment period, a post-treatment safety follow-up (30 days) followed by a long-term follow-up period.

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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Metastatic Hormone-sensitive Prostate Cancer

Keywords

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Interventional clinical trial open-label JSB462 luxdegalutamide efficacy safety tolerability abiraterone metastatic hormone-sensitive prostate cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

JSB462 100 mg QD + abiraterone 1000 mg QD

Group Type EXPERIMENTAL

JSB462

Intervention Type DRUG

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

Intervention Type DRUG

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

Group Type EXPERIMENTAL

JSB462

Intervention Type DRUG

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

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Abiraterone

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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luxdegalutamide

Eligibility Criteria

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Inclusion Criteria

* An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2
* 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

* Prior exposure to a second generation ARPI (such as enzalutamide/darolutamide/apalutamide and/or abiraterone) for the treatment of advanced/metastatic disease is not allowed. Prior exposure to ARPI, to taxane chemotherapy (up to 6 cycles) or to RLT in the context of (neo)adjuvant treatment for localized prostate cancer is allowed, if the last dose of this treatment was administered \>12 months from randomization. Prior use of a first generation ARPI (such as bicalutamide) in the context of ADT initiation with a GnRH analog is allowed, provided the first generation ARPI was administered for ≤14 days and last dose was administered ≥7 days from randomization.
* Participants with biochemical recurrence only or those without evidence of metastatic disease by radiological imaging (CT/MRI or bone scan) are not eligible
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status RECRUITING

Emory University School of Medicine-Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

XCancer Omaha LLC

Omaha, Nebraska, United States

Site Status RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site Status RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status RECRUITING

Urology San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status RECRUITING

Novartis Investigative Site

Adelaide, South Australia, Australia

Site Status RECRUITING

Novartis Investigative Site

Clayton, Victoria, Australia

Site Status RECRUITING

Novartis Investigative Site

Brno, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Nice, Alpes Maritimes, France

Site Status RECRUITING

Novartis Investigative Site

Marseille, , France

Site Status RECRUITING

Novartis Investigative Site

Suresnes, , France

Site Status RECRUITING

Novartis Investigative Site

Hamburg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Nürtingen, , Germany

Site Status RECRUITING

Novartis Investigative Site

Verona, VR, Italy

Site Status RECRUITING

Novartis Investigative Site

Zwolle, Overijssel, Netherlands

Site Status RECRUITING

Novartis Investigative Site

Hoofddorp, , Netherlands

Site Status RECRUITING

Novartis Investigative Site

Schiedam, , Netherlands

Site Status RECRUITING

Novartis Investigative Site

Kielce, , Poland

Site Status RECRUITING

Novartis Investigative Site

Oświęcim, , Poland

Site Status RECRUITING

Novartis Investigative Site

Skorzewo, , Poland

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Badajoz, Extremadura, Spain

Site Status RECRUITING

Novartis Investigative Site

Lugo, Galicia, Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Tainan, , Taiwan

Site Status RECRUITING

Countries

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United States Australia Czechia France Germany Italy Netherlands Poland Singapore South Korea Spain Taiwan

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Facility Contacts

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Annie Sauve

Role: primary

Emily Setser

Role: primary

Tony Romero

Role: primary

Gianna Lewis

Role: primary

Taylor Stephenson

Role: primary

Jessica Ward

Role: primary

Emilia Aguilar

Role: primary

Chris Morris

Role: primary

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