JSB462 + Abiraterone for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: GnRH analog/antagonist

Must not be taking: Second generation ARPI

Disqualifiers: Neuroendocrine, Biochemical recurrence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adult males with metastatic hormone-sensitive prostate cancer. Participants must have a specific level of physical functioning (ECOG PS ≤2), confirmed adenocarcinoma without neuroendocrine elements, and meet certain criteria regarding the spread and volume of their cancer. They should also have testosterone levels indicating they are castrate-resistant, but not yet achieved PSA zero despite ongoing treatment.

Inclusion Criteria

I have advanced prostate cancer with specific spread to bones and/or organs.

My testosterone levels are very low, and I've been on hormone therapy for less than 3 months without my PSA dropping to zero.

Key

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive JSB462 (100 mg or 300 mg QD) and abiraterone (1000 mg QD) or enzalutamide (160 mg QD) until disease progression or other criteria are met

Post-treatment Safety Follow-up

Participants are monitored for safety after treatment discontinuation

4 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for safety, efficacy, and survival information until the end of the study

What Are the Treatments Tested in This Trial?

Interventions

• JSB462 (Luxdegalutamide)

Trial Overview The study tests JSB462 (luxdegalutamide) in two doses combined with abiraterone against standard treatments for advanced prostate cancer. It's a Phase II trial to determine the effectiveness, safety, tolerability, and pharmacokinetics to decide on an optimal dose for future studies.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 2 Interventions

JSB462 300 mg QD + abiraterone 1000 mg QD

Group II: Arm 1 Experimental Treatment 2 Interventions

JSB462 100 mg QD + abiraterone 1000 mg QD

Group III: Arm 3 Active Control 2 Interventions

abiraterone 1000 mg QD or enzalutamide 160 mg QD

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD