Summary
You may be eligible for this study if you have metastatic castration resistant prostate cancer (mCRPC) and have prior exposure to at least 1 Adrogen Receptor Pathway Inhibitor (ARPI) and 0-2 taxane treatment regimens.
It is evaluating how safe and effective the combination of the oral androgen receptor degrader JSB462 (also known as luxdegalutamide) and a targeted radioligand therapy called AAA617, compared to treatment with AAA617 alone. Twoi dose levels of JSB462 will be evaluated.
This study consists of a screening period, a treatment period, a post-treatment safety follow-up followed by a long-term follow-up period.
Eligible participants will be randomly allocated to one of three treatment arms. JSB462 administration begins at Day 1 of randomisation, whereas AAA617 administration starts at Day 1 of the treatment period. Arms 1 and 2 will therefore receive JSB during the 14-day randomisation period before the first administration of AAA617.
JSB462 is given orally, daily and continuously at one of two dose levels (100mg or 300mg) depending on which Arm you are in.
AAA617 will be administered intravenously every 6 weeks for up to 6 doses unless there is disease progression.
During the post-treatment period:
- Safety follow-up: After discontinuation of study treatment, all participants will be followed for at least 1 safety follow-up visit (around 30 days after end of treatment visit). Subsequent lines of therapy may be given 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 the study. Safety, efficacy and survival information may be collected from the participants during this period.