New drug JSB462 tested for advanced prostate cancer in japanese patients
NCT ID NCT07174063
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times
Summary
This early-stage study tests a new drug called JSB462 (Luxdegalutamide) in 15 Japanese men whose prostate cancer has spread to other parts of the body. The main goal is to check the drug's safety and how the body processes it. Participants take the drug once daily with food.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JSB462 (Luxdegalutamide)
- What this could lead to
- If safe and effective, this drug could offer a new treatment option for Japanese men with advanced prostate cancer that has spread.
- What could go wrong
- This is a very early Phase 1 trial with only 15 participants, so it's too soon to know if the drug works. Side effects are unknown and could be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Nov 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Novartis Investigative Site
Nagoya, Aichi-ken, 4668560, Japan
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Novartis Investigative Site
Kobe, Hyōgo, 6500017, Japan
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Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138677, Japan
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Novartis Investigative Site
Koto Ku, Tokyo, 1358550, Japan
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