An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Recruiting
Phase 2
Interventional Study
Metastatic Hormone-sensitive Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Novartis Pharmaceuticals · Industry
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About This Trial
This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phas…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria:
* An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2
* Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible
* High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non…
Contacts