A phase Ib/II open-label, multi-center study of the DNA protein kinase inhibitor AMO959 with lutetium [177Lu] vipivotide tetraxetan [AAA617] in combination with an androgen receptor pathway inhibitor [ARPI] in adult participants with PSMA-positive metastatic castration resistant prostate cancer [mCRPC]. (NCT06894511)

The purpose of this study is to assess safety of combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI and AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the metastic castrate resistant prostate cancer (mCRPC) setting.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Mark Voskoboynik

Key inclusion data

Participants must have histopathological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants must have an ECOG performance status of 0 to 2. Participants must have mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI). Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol and are eligible as determined by the sponsor’s central reading rules. Prior treatment with any RLT or PSMA-targeted agents (approved or investigational) is not allowed.