Metastatic Prostate Cancer (mCRPC)Phase 1NCT07174063
A Phase I Study of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
A Phase 1 study testing JSB462 in people with Metastatic Prostate Cancer (mCRPC), run by Novartis Pharmaceuticals at 4 sites in Japan.
Trial summary
This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Metastatic Prostate Cancer (mCRPC)
- What is being tested?
- JSB462
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesJapan
- Study dates
- 26 Nov 2025to 29 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138677
Novartis Investigative Site
Kobe, Hyōgo, 6500017
Novartis Investigative Site
Koto Ku, Tokyo, 1358550
Novartis Investigative Site
Nagoya, Aichi-ken, 4668560
About this study
Official title: An Open-label, Single-arm Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
This Phase I study aims to evaluate the safety, tolerability and PK of JSB462 in Japanese patients with metastatic prostate cancer.
Read the 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 be evaluated in the first (28-day) cycle. If 300 mg once a day (QD) is considered intolerable by investigators and Novartis study personnel during dose evaluation meeting, the tolerability of 100 mg QD dose level cohort may be assessed.
Study treatment will be administered until disease progression (per PCWG3-modified RECIST v1.1 assessed by the investigator), unacceptable toxicity, death, withdrawal of consent, lost to follow-up or investigator's decision.
The End of Treatment Visit and the Safety Follow-up Visit will be performed within 7 days and 30 days from the last dose of JSB462, respectively. If participants discontinue study treatment for reasons other than disease progression (per PCWG3-modified RECIST v1.1 assessed by the investigator), death, lost to follow-up, or withdrawal of consent, then tumor assessments should continue to be performed in the Efficacy Follow-up Visit according to the planned schedule until disease progression (per PCWG3-modified RECIST v1.1 assessed by the investigator), death, withdrawal of consent or lost to follow-up.
- Conditions
- Metastatic Prostate Cancer (mCRPC)
- Being tested
- JSB462
- Keywords
- metastatic prostate cancer (mCRPC), JSB462, luxdegalutamide, open-label
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JSB462Drug
300 mg or 100 mg once a day (QD) with food
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Participants will receive JSB462 orally, daily and continuously (100 mg or 300 mg QD). Receives: Drug: JSB462 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment
A dose-limiting toxicity (DLT) is defined as a treatment-related adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the first 28 days of treatment with JSB462 and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. For the purpose of dose regimen decisions, DLTs will be considered.
Measured: Up to 28 days
Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
Measured: Through study completion, an average of approximately 18 months
Number of Participants with dose adjustments
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by means of descriptive statistics.
Measured: From date of randomization till 30 days safety fup, assessed up to approximately 18 months
Dose Intensity
Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be summarized by means of descriptive statistics.
Measured: From date of randomization till 30 days safety fup, assessed up to approximately 18 months
Plasma concentrations of JSB462 and its metabolite ARV-767
JSB462 pharmacokinetic (PK) samples will be obtained and evaluated to assess single dose and steady-state plasma Pharmacokinetic (PK) of JSB462 and its metabolite ARV-767 and summarized using descriptive statistics.
Measured: Cycle 1: Days 1 & 21 (0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Days 2 & 22 (0 hour). Cycles 2-6: Day 1 (0 hour). End of Treatment Visit (EOT): within 7 days from the last dose of JSB462. 1 cycle = 28 days.
AUC of JSB462
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) will be listed and summarized using descriptive statistics.
Measured: Cycle 1: Days 1 & 21 (0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Days 2 & 22 (0 hour). Cycles 2-6: Day 1 (0 hour). End of Treatment Visit (EOT): within 7 days from the last dose of JSB462. 1 cycle = 28 days.
Cmax of JSB462
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Measured: Cycle 1: Days 1 & 21 (0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Days 2 & 22 (0 hour). Cycles 2-6: Day 1 (0 hour). End of Treatment Visit (EOT): within 7 days from the last dose of JSB462. 1 cycle = 28 days.
Tmax of JSB462
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
Measured: Cycle 1: Days 1 & 21 (0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Days 2 & 22 (0 hour). Cycles 2-6: Day 1 (0 hour). End of Treatment Visit (EOT): within 7 days from the last dose of JSB462. 1 cycle = 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start26 Nov 2025
- Primary completion29 Jan 2027 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174063
- Sponsor's protocol ID
- CJSB462A11101
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT07174063
- Acronym / sponsor ID
- CJSB462A11101
- Conditions
- Metastatic Prostate Cancer (mCRPC)
- Keywords
- metastatic prostate cancer (mCRPC), JSB462, luxdegalutamide, open-label
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 be evaluated in the first (28-day) cycle. If 300 mg once a day (QD) is considered intolerable by investigators and Novartis study personnel during dose evaluation meeting, the tolerability of 100 mg QD dose level cohort may be assessed.
Study treatment will be administered until disease progression (per PCWG3-modified RECIST v1.1 assessed by the investigator), unacceptable toxicity, death, withdrawal of consent, lost to follow-up or investigator's decision.
The End of Treatment Visit and the Safety Follow-up Visit will be performed within 7 days and 30 days from the last dose of JSB462, respectively. If participants discontinue study treatment for reasons other than disease progression (per PCWG3-modified RECIST v1.1 assessed by the investigator), death, lost to follow-up, or withdrawal of consent, then tumor assessments should continue to be performed in the Efficacy Follow-up Visit according to the planned schedule until disease progression (per PCWG3-modified RECIST v1.1 assessed by the investigator), death, withdrawal of consent or lost to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: JSB462Participants will receive JSB462 orally, daily and continuously (100 mg or 300 mg QD). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JSB462300 mg or 100 mg once a day (QD) with food | Drug | Arm 1 |
Primary outcome
Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment
Time frame: Up to 28 days
A dose-limiting toxicity (DLT) is defined as a treatment-related adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the first 28 days of treatment with JSB462 and meets any of the criteria specified in the protocol. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5.0 will be used for all grading. For the purpose of dose regimen decisions, DLTs will be considered.
Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Through study completion, an average of approximately 18 months
The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
Number of Participants with dose adjustments
Time frame: From date of randomization till 30 days safety fup, assessed up to approximately 18 months
The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by means of descriptive statistics.
Dose Intensity
Time frame: From date of randomization till 30 days safety fup, assessed up to approximately 18 months
Dose intensity (computed as the ratio of actual cumulative dose received and actual duration of exposure) and the relative dose intensity (computed as the ratio of dose intensity and planned dose intensity) will be summarized by means of descriptive statistics.
Plasma concentrations of JSB462 and its metabolite ARV-767
Time frame: Cycle 1: Days 1 & 21 (0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Days 2 & 22 (0 hour). Cycles 2-6: Day 1 (0 hour). End of Treatment Visit (EOT): within 7 days from the last dose of JSB462. 1 cycle = 28 days.
JSB462 pharmacokinetic (PK) samples will be obtained and evaluated to assess single dose and steady-state plasma Pharmacokinetic (PK) of JSB462 and its metabolite ARV-767 and summarized using descriptive statistics.
AUC of JSB462
Time frame: Cycle 1: Days 1 & 21 (0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Days 2 & 22 (0 hour). Cycles 2-6: Day 1 (0 hour). End of Treatment Visit (EOT): within 7 days from the last dose of JSB462. 1 cycle = 28 days.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) will be listed and summarized using descriptive statistics.
Cmax of JSB462
Time frame: Cycle 1: Days 1 & 21 (0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Days 2 & 22 (0 hour). Cycles 2-6: Day 1 (0 hour). End of Treatment Visit (EOT): within 7 days from the last dose of JSB462. 1 cycle = 28 days.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Tmax of JSB462
Time frame: Cycle 1: Days 1 & 21 (0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 8 hours), Days 2 & 22 (0 hour). Cycles 2-6: Day 1 (0 hour). End of Treatment Visit (EOT): within 7 days from the last dose of JSB462. 1 cycle = 28 days.
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JSB462 in people with Metastatic Prostate Cancer (mCRPC), run by Novartis Pharmaceuticals at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment (time frame: Up to 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.