An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Conditions

• Metastatic Hormone-sensitive Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• JSB462 — 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 — 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 — 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.

Study Details

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

Key Dates

First listed

May 28, 2025

Start date

Jul 7, 2025

Status verified

Sep 2026

Primary completion

Feb 13, 2032

Completion

Sep 4, 2035

Study Design

Enrollment

168 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  JSB462 100 mg QD + abiraterone 1000 mg QD
• Experimental: Arm 2
  JSB462 300 mg QD + abiraterone 1000 mg QD
• Active Comparator: Arm 3
  abiraterone 1000 mg QD or enzalutamide 160 mg QD

Primary Outcome Measure

Prostate Specific Antigen 90 (PSA90) Rate [ Time Frame: From date of randomization till 30 days safety fup, assessed up to approximately 75 months ]

Locations (21)

Find similar trials in La Jolla, CA

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