Phase I testing of JSB462 (luxdegalutamide) in Japanese men with metastatic prostate cancer
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 test will see if JSB462 (luxdegalutamide) is safe and how the body handles it in Japanese men with metastatic prostate cancer who have limited standard treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | Novartis Industry-sponsored |
| Locations | 4 sites (Nagoya, Aichi-ken and 3 other locations) |
| Trial ID | NCT07174063 on ClinicalTrials.gov |
What this trial studies
This open-label Phase I trial gives JSB462 (luxdegalutamide) orally starting at 300 mg once daily to Japanese men with metastatic prostate cancer to characterize safety, tolerability, and pharmacokinetics. Dose-limiting toxicities will be evaluated during a 28-day first cycle, and if 300 mg is not tolerable the protocol allows testing a 100 mg once-daily cohort. Treatment continues until disease progression per PCWG3-modified RECIST v1.1, unacceptable toxicity, death, withdrawal, or investigator decision, with tumor assessments continued during efficacy follow-up. Key inclusion criteria include histologically confirmed prostate adenocarcinoma with at least one bone or visceral metastasis, castrate-level testosterone, ECOG 0–1, and prior failure, intolerance, or ineligibility for standard therapies, while patients with CNS metastases or other active malignancies are excluded.
Who should consider this trial
Good fit: Ideal candidates are Japanese adult men with histologically confirmed metastatic prostate adenocarcinoma (at least one bone or visceral lesion), castrate testosterone levels, ECOG performance status 0–1, who have failed, refused, or are ineligible for standard therapies.
Not a fit: Patients with CNS metastases, only nodal disease, other active malignancies, or those who still have effective approved standard treatment options are unlikely to benefit from this early-phase trial.
Why it matters
Potential benefit: If JSB462 is safe and tolerable, it could become an additional oral treatment option to help control metastatic prostate cancer and delay disease progression.
How similar studies have performed: Other androgen-receptor–targeting drugs have shown clinical benefit in metastatic prostate cancer, but JSB462 itself is in early human testing and not yet proven effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nagoya, Aichi-ken and 3 other locations
- Novartis Investigative Site — Nagoya, Aichi-ken, Japan (Active_not_recruiting)
- Novartis Investigative Site — Bunkyo Ku, Tokyo, Japan (Recruiting)
- Novartis Investigative Site — Koto Ku, Tokyo, Japan (Recruiting)
- Novartis Investigative Site — Kobe, Japan (Active_not_recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +81337978748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.