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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07174063
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Prostate Cancer (mCRPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • JSB462 — DRUG
    300 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

Start date
Nov 14, 2025
Status verified
Jun 2026
Primary completion
Jun 18, 2027
Completion
Jun 18, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Participants 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 ]

Central Contacts