Actively Recruiting
A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
Led by Novartis Pharmaceuticals · Updated on 2026-04-28
15
Participants Needed
4
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer.
CONDITIONS
Official Title
A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male adults with confirmed adenocarcinoma of the prostate
- Presence of at least one bone or visceral metastatic lesion on recent imaging within 28 days before enrollment
- Failed or refused standard therapies for prostate cancer, or ineligible or intolerant to such therapies
- Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L); ongoing androgen deprivation therapy allowed
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
You will not qualify if you...
- Presence of central nervous system (CNS) metastases
- Any active malignancy other than prostate cancer, except for certain treated cancers with no recurrence for at least 3 years or specific skin cancers treated curatively
- Other exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 4668560
Active, Not Recruiting
2
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 1138677
Actively Recruiting
3
Novartis Investigative Site
Koto Ku, Tokyo, Japan, 1358550
Actively Recruiting
4
Novartis Investigative Site
Kobe, Japan, 650-0017
Active, Not Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals, +41613241111
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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