RecruitingPhase 1NCT07174063

A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer

An Open-label, Single-arm Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer


Sponsor

Novartis Pharmaceuticals

Enrollment

15 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This phase I study is testing a drug called JSB462 (luxdegalutamide) — a new type of androgen receptor degrader — in Japanese men with metastatic prostate cancer who have progressed on standard hormone therapy. The study is checking safety and finding the right dose. **You may be eligible if...** - You are a man with confirmed prostate cancer that has spread to bones or other organs (not just lymph nodes) - Your prostate cancer has failed or is not eligible for standard hormone treatments - Your testosterone levels are at castrate levels (very low, as achieved by hormone therapy or surgical removal of testes) - You are in good physical condition (ECOG 0–1) **You may NOT be eligible if...** - Your prostate cancer has spread to the brain - You have another active cancer - You have had a prior cancer that might recur or interfere Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGJSB462

300 mg or 100 mg once a day (QD) with food


Locations(4)

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Koto Ku, Tokyo, Japan

Novartis Investigative Site

Kobe, Japan

View Full Details on ClinicalTrials.gov

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NCT07174063