The purpose of this study is to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, preliminary anti-tumor activity, and recommended dose of INR731 as a single agent and in combination with standard-of-care androgen receptor pathway inhibitors (ARPIs) in adult patients with metastatic prostate cancer.
An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2.
Participants must have histological and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are eligible as long as the non-adenocarcinoma feature is the minority component.
At least 1 metastatic lesion (according to local radiology assessment by the investigator) present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to Cycle 1 Day 1 (C1D1).
Patients must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
Age < 18 years old.
Histological and/or cytological confirmation of non-adenocarcinoma of the prostate.
Patients with biochemical recurrence only or those without evidence of metastatic disease by radiographical imaging (CT/MRI or bone scan) are not eligible.
Patients previously treated with a cereblon-based degrader.