A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT07174063
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Metastatic Prostate Cancer (mCRPC)
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- JSB462 — DRUG300 mg or 100 mg once a day (QD) with food
Study Details
This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer.
Key Dates
- First listed
- Sep 15, 2025
- Start date
- Nov 26, 2025
- Status verified
- Jul 2026
- Primary completion
- Jan 29, 2027
- Completion
- Jan 29, 2027
Study Design
- Enrollment
- 6 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1Participants will receive JSB462 orally, daily and continuously (100 mg or 300 mg QD).
Primary Outcome Measure
Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment [ Time Frame: Up to 28 days ]