JSB462 + Lutetium for Prostate Cancer

Recruiting at 29 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Androgen receptor inhibitors

Must not be taking: Radioligand therapy, Protein degraders

Disqualifiers: Neuroendocrine histology, 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: 8

Duration: 24-36 weeks

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments to evaluate their safety and effectiveness for men with a specific type of prostate cancer that has spread and resists regular hormone therapy. The study compares two different doses of a new drug, JSB462 (Luxdegalutamide, an experimental treatment), combined with lutetium, against lutetium alone. Men who have previously tried at least one hormone-blocking treatment and possibly up to two rounds of chemotherapy may be eligible. The trial aims to identify the best dose for the next research phase by assessing treatment efficacy and the body's response. As a Phase 2 trial, the research focuses on measuring treatment effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that JSB462 (luxdegalutamide) was tested for safety in earlier studies. In these studies, patients with advanced prostate cancer tolerated the treatment well. Most patients managed JSB462 effectively, though some experienced mild to moderate side effects, such as tiredness or nausea.

For AAA617, also known as lutetium vipivotide tetraxetan, previous studies support its use in prostate cancer with manageable safety concerns. Common side effects include dry mouth and nausea, while serious side effects are less common but can occur.

Since this trial is in Phase II, earlier research provides some safety data, suggesting a reasonable level of safety. Ongoing trials will help confirm this further. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about JSB462 (Luxdegalutamide) for prostate cancer because it introduces a new approach by combining it with Lutetium-177, a radiolabeled compound known as AAA617. Unlike traditional treatments like hormone therapy or chemotherapy, JSB462 targets androgen receptors directly, which are critical in prostate cancer growth, while Lutetium-177 delivers targeted radiotherapy. This combination aims to enhance cancer cell destruction with precision, potentially offering a more effective and less toxic alternative to existing therapies. The dual-action of hormone blockade and targeted radiation could mean better outcomes and fewer side effects for patients.

What evidence suggests that this trial's treatments could be effective for metastatic Castration Resistant Prostate Cancer?

Research has shown that combining JSB462 (luxdegalutamide) with lutetium (177Lu) vipivotide tetraxetan may offer promise for treating advanced prostate cancer that no longer responds to hormone therapy. In this trial, participants in Arm 1 and Arm 2 will receive different dosages of JSB462 with lutetium. Previous patients experienced a significant drop in prostate-specific antigen (PSA) levels, indicating the treatment's effectiveness. This combination aims to target cancer cells more precisely, potentially leading to better outcomes. Although detailed human data remains limited, the interaction of these treatments suggests they could enhance the ability to fight cancer. Early findings are encouraging, and further research will help confirm these results. ^{1 2 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 individuals with metastatic Castration Resistant Prostate Cancer (mCRPC) who have previously been treated with at least one Androgen Receptor Pathway Inhibitor and up to two taxane regimens. Specific eligibility criteria details are not provided.

Inclusion Criteria

Participants must be [68Ga]Ga-PSMA-11 PET/CT scan positive and eligible as determined by the sponsor's central reader.

I am a man diagnosed with prostate cancer, not mixed with neuroendocrine types.

I can perform daily activities with minimal assistance.

Exclusion Criteria

I have never had radio-ligand therapy.

I have never been treated with drugs that target AR by breaking down proteins.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization

Participants are randomized to receive either JSB462 in combination with AAA617 or AAA617 alone

2 weeks

1 visit (in-person)

Treatment

Participants receive JSB462 daily and AAA617 every 6 weeks for up to 6 doses

24-36 weeks

6 visits (in-person)

Safety Follow-up

Participants are monitored for safety 30 days after the end of treatment

4 weeks

1 visit (in-person)

Long-term Follow-up

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

Up to 41 months

What Are the Treatments Tested in This Trial?

Interventions

• JSB462 (Luxdegalutamide)
• Lutetium (177Lu) Vipivotide Tetraxetan

Trial Overview The study tests the effectiveness and safety of combining JSB462 (luxdegalutamide) in two doses, 100 mg and 300 mg daily, with lutetium (177Lu) vipivotide tetraxetan (AAA617), compared to AAA617 alone in mCRPC patients.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 2 Interventions

JSB462 300 mg QD + AAA617 7.4 GBq Q6W

Group II: Arm 1 Experimental Treatment 2 Interventions

JSB462 100 mg QD + AAA617 7.4 GBq Q6W

Group III: Arm 3 Active Control 1 Intervention

AAA617 7.4 GBq Q6W

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/NCT07047118

NCT07047118 | A Study of JSB462 (Luxdegalutamide) ... This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + ...

2. trialx.com trialx.com/clinical-trials/listings/323005/a-study-of-jsb462-luxdegalutamide-plus-lutetium-177lu-vipivotide-tetraxetan-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc/

A Study of JSB462 (Luxdegalutamide) Plus Lutetium ... Overview. This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 ...

3. theranostictrials.org theranostictrials.org/studies/clsupindl001l11ujhnhud8tu/study/NCT07047118

NCT07047118 This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + ...

4. novartis.com novartis.com/clinicaltrials/study/nct07047118

A Study of JSB462 (Luxdegalutamide) Plus Lutetium ... This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT07047118

A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu ... Prostate Specific Antigen 90 (PSA90) Rate is defined as the proportion of participants who achieve a ≥90% decrease in PSA from baseline at any timepoint, ...

6. 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) ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07174063

A Phase I Study of JSB462 (Luxdegalutamide) in Japanese ... This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer.

8. clin.larvol.com clin.larvol.com/trial-detail/NCT06991556

An Open-label Study of JSB462 (Luxdegalutamide) in ... Prostate Specific Antigen 90 (PSA90) Rate · Incidence rate of adverse events (AEs) · Number of participants with dose adjustments · Duration of exposure to study ...