JSB462 + Abiraterone for Prostate Cancer

Recruiting at 41 trial locations

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 trial tests a new treatment combination for metastatic hormone-sensitive prostate cancer. It evaluates the effectiveness of JSB462 (luxdegalutamide, an experimental treatment) with abiraterone compared to existing treatments. Two test groups receive different JSB462 doses, while a comparison group uses standard drugs. Men with prostate cancer that has spread to bones or organs and who have not yet received advanced hormone therapies are suitable candidates for this trial. The trial aims to determine the best dose for future studies while assessing the treatment's safety and effectiveness. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have taken certain prostate cancer treatments like enzalutamide or abiraterone for advanced disease, you may not be eligible. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that JSB462, also known as luxdegalutamide, is a promising new treatment for prostate cancer. Early results from previous studies suggest that this drug is generally well-tolerated. Specifically, patients with certain genetic mutations responded well to the treatment, with 43% experiencing a significant drop in prostate-specific antigen (PSA) levels, a marker used to track prostate cancer progression.

Regarding the safety of using JSB462 with abiraterone, current research has not identified any major safety concerns. Since this treatment is in a Phase 2 trial, it has already passed initial safety checks from earlier studies. Abiraterone, a drug already approved for prostate cancer, is widely used, with its safety well-documented. However, side effects and tolerance can vary, so participants should discuss any concerns with their doctors. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Luxdegalutamide (JSB462) is unique because it offers a novel approach to treating prostate cancer. Unlike current standard treatments like abiraterone or enzalutamide, Luxdegalutamide is being tested in combination with abiraterone to potentially enhance the effectiveness of hormone therapy. Researchers are excited about Luxdegalutamide because it targets androgen receptors more precisely, which may improve outcomes and reduce side effects often seen with other therapies. By exploring different dosages in combination with abiraterone, this treatment could provide a more personalized and effective option for patients battling prostate cancer.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

This trial will evaluate the combination of JSB462 (also known as luxdegalutamide) with abiraterone for treating metastatic Hormone Sensitive Prostate Cancer (mHSPC). Participants will receive either JSB462 at varying dosages combined with abiraterone or abiraterone alone as an active comparator. Research indicates that JSB462 is a potent drug designed to alter the androgen receptor, which plays a crucial role in prostate cancer growth. Early findings suggest that combining JSB462 with abiraterone may be more effective than using abiraterone alone. This combination aims to block the cancer's growth signals more effectively. While more information is needed, these early results offer promise for patients with this type of prostate cancer. ^{3 4 6 7 8}

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06991556

NCT06991556 | An Open-label Study of JSB462 ... 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) ...

2. ctv.veeva.com ctv.veeva.com/study/an-open-label-study-of-jsb462-luxdegalutamide-in-combination-with-abiraterone-in-adult-male-patien

An Open-label Study of JSB462 (Luxdegalutamide) in ... 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) ...

3. withpower.com withpower.com/trial/phase-2-hypesthesia-6-2025-1153b

JSB462 + Abiraterone for 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.

4. urotoday.com urotoday.com/conference-highlights/esmo-2025/esmo-2025-prostate-cancer/164136-esmo-2025-targeting-androgen-receptor-alterations-in-prostate-cancer.html

Targeting Androgen Receptor Alterations in Prostate Cancer ... JSB462 (luxdegalutamide), with initial results presented by Dr. Petrylak at ASCO 2024. This agent is a novel, potent, orally administered ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10854644/

Insight into Recent Advances in Degrading Androgen ... The phase I trial (NCT03888612) results suggested that ARV-110 is well-tolerated by the participants at doses up to 420 mg, effectively ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06991556

NCT06991556 | An Open-label Study of JSB462 ... 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) ...

7. novartis.com novartis.com/clinicaltrials/study/nct06991556

An Open-label Study of JSB462 (Luxdegalutamide) in ... 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) ...

8. prostatewarriors.com prostatewarriors.com/2025/05/29/phase-2-clinical-trial-jsb462-luxdegalutamide-in-combination-with-abiraterone-for-mhspc/

Phase 2 Clinical Trial: JSB462 (Luxdegalutamide) in ... In that study, patients with AR mutations like L702H showed a 43% PSA50 response rate (a 50% or greater reduction in prostate-specific antigen ...