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 phase III. Towards that end, the totality of
the efficacy, safety, tolerability and PK data from participants randomized in the study
will be evaluated
Additional locations may be listed on ClinicalTrials.gov for NCT06991556.
See trial information on ClinicalTrials.gov for a list of participating sites.
The study for each participant consists of a Screening period (28 days), a treatment
period, a post-treatment safety follow-up (30 days) followed by a long-term follow-up
period.
During the treatment period:
- JSB462 is administered from randomization, orally, daily and continuously (100 mg or
300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by
the investigator, the occurrence of unacceptable toxicities, death, participant
decision or investigator decision.
- Abiraterone 1000 mg or enzalutamide 160 mg are administered from randomization,
orally, daily, and continuously until disease progression per PCWG3-modified RECIST
1.1 as assessed by the investigator, the occurrence of unacceptable toxicities,
death, participant decision or investigator decision.
During the post-treatment follow up period:
- Safety follow-Up: After discontinuation of study treatment, all participants will be
followed for at least 1 safety follow-up visit (30 days [+/- 7 days] after treatment
discontinuation). Subsequent lines of therapy may be administered according to
investigator's discretion after treatment discontinuation.
- Long-term follow-up: Starts after the Safety follow-up period and lasts until the
end of study. Safety, efficacy and survival information may be collected from
participants during this period.
Lead OrganizationNovartis Pharmaceuticals Corporation