Status:
NOT_YET_RECRUITING
A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Prostate Cancer (mCRPC)
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer.
Detailed Description
Participants will receive JSB462 at the starting dose of 300 mg QD to evaluate its safety, tolerability and PK. Any Adverse Events (AEs) and Dose Limiting Toxicities (DLTs) will be assessed. DLTs will...
Eligibility Criteria
Inclusion
- Key
- Adult male patients with histologically or cytologically confirmed and documented adenocarcinoma of the prostate.
- At least 1 bone or visceral metastatic lesion (according to local radiology assessment by the investigator) present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to enrollment. Lymph nodes as only site of metastases are not allowed.
- Patients with prostate cancer must have failed or refused available standard therapies, be intolerant or ineligible to receive such therapy, or for whom no standard therapy exists.
- Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Ongoing ADT (as defined by prior orchiectomy and/or ongoing GnRH analog/antagonist) is allowed prior to enrollment.
- Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1.
- Key
Exclusion
- Patients with CNS metastases.
- Patients with any other active malignancy other than prostate cancer. Exceptions to this criterion include the following: malignancies that were treated curatively at least 3 years before starting study treatment which have not recurred; basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative local therapy or other tumors that will not affect life expectancy.
- Other inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 18 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07174063
Start Date
December 26 2025
End Date
June 18 2027
Last Update
December 9 2025
Active Locations (1)
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1
Novartis Investigative Site
Koto Ku, Tokyo, Japan, 135 8550