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NCT Number: NCT07174063

A Phase I Study 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Prostate Cancer (mCRPC) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JSB462

Drug

300 mg or 100 mg once a day (QD) with food

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Open-label, Single-arm Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JSB462 (Luxdegalutamide) in Japanese Patients With Metastatic Prostate Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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