The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in participants with mCRPC who have failed one prior ARPI, but who have not yet been exposed to taxane treatment.
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Phase Ib: Incidence rate of Dose-limiting toxicities (DLTs)
Timeframe: Up to 42 days after the first AAA617 dose administration
Phase Ib: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From date of start of study treatment, assessed up to approximately 45 months
Phase Ib: Number of Participants with dose adjustments
Timeframe: From date of start of study treatment, assessed up to approximately 24 months
Phase Ib: Dose Intensity
Timeframe: From date of start of study treatment, assessed up to approximately 24 months
Phase Ib: Duration of exposure to each study drug
Timeframe: From date of start of study treatment, assessed up to approximately 24 months
Phase II: Biochemical Response (PSA50)
Timeframe: From date of start of study treatment, assessed up to approximately 24 months