Phase IbII Study Evaluating AMO959 With Lutetium 177Lu Vipivotide Tetraxetan and Androgen Receptor Pathway Inhibitors in Adult Men with PSMA-positive Metastatic Castration Resistant Prostate Cancer

What this Trial Is About

Researchers are studying a treatment approach for adult men with PSMA-positive metastatic castration resistant prostate cancer mCRPC who have previously received one androgen receptor pathway inhibitor ARPI and may or may not have had taxane chemotherapy. This phase IbII trial aims to first evaluate the safety, tolerability, and how the body processes the drug AMO959 combined with lutetium 177Lu vipivotide tetraxetan AAA617 and ARPI. Then, it will assess the preliminary effectiveness of this combination in patients who have not yet been treated with taxane chemotherapy for mCRPC. The study includes two phases Phase Ib with small groups receiving escalating doses of AMO959 alone, then combined with AAA617 and ARPI abiraterone or enzalutamide to determine the recommended dose and Phase II where participants are assigned to treatment arms receiving AMO959 with AAA617 and ARPI, AAA617 with ARPI, or other dosing regimens. Treatments involve taking AMO959 twice daily for 14 days followed by combinations with AAA617 every six weeks for up to six cycles, along with continuous ARPI therapy. Participants will undergo safety monitoring for side effects and dose adjustments during treatment lasting up to about two years. The study measures include biochemical responses like PSA levels, progression-free survival, overall response rates, and quality of life assessments. Blood samples will track drug levels and radiation doses. Follow-up continues to monitor adverse events and disease progression for up to nearly four years from treatment start, with regular visits during treatment cycles.

A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC