Randomized Study of ONC-392 plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who Progressed on Androgen Receptor (AR) Pathway Inhibition

Brief description of study

This study wants to see if a new immunotherapy treatment called ONC-392, combined with Lu 177 vipivotide (Pluvicto) compared to Lu 177 vipivotide (Pluvicto) alone, can help people with metastatic castration-resistant prostate cancer (mCRPC). The people in the study have already tried one kind of treatment that didn't work (prior androgen receptor-targeted therapy, ARTA), and they haven't had Lu 177 vipivotide before. The study will start by testing different dosage amounts of ONC-392 to find the safest one to use with Lu 177 vipivotide. After that, they'll give the highest dose with few side effects to more people to see if it works well. Patients will be monitor for side effects, undergo imaging (scans), and undergo blood tests regularly. The study will also keep track of cancer control, patient survival, and side effects.

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