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.
Sequential
INR731
DrugOral administration
Enzalutamide
DrugOral administration
Abiraterone
DrugOral administration
Androgen deprivation therapy (ADT)
DrugBackground therapy. Patients will continue receiving ADT throughout this clinical study as part of the standard of care.
Incidence and severity of dose-limiting toxicities (DLTs)
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 that occurs within the first 28 days and not clearly and incontrovertibly assessed as due to disease progression, intercurrent illness, concomitant medication, or extraneous causes with the exceptions defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and electrocardiograms (ECGs) qualifying and reported as AEs.
Frequency of dose interruptions and reductions
Number of participants with dose interruptions and/or reductions to assess the tolerability.
Dose intensity
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
Overall Response Rate (ORR)
ORR is defined as proportion of patients achieving a confirmed complete response (CR) or partial response (PR) per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by the investigator.
Disease Control Rate (DCR)
DCR is defined as proportion of patients achieving a CR, PR or stable disease (SD) per PCWG3-modified RECIST v1.1 as assessed by the investigator.
Radiological Progression Free Survival (rPFS)
rPFS is defined as the time from the date of start of treatment to the date of the first documented radiological progression according to PCWG3-modified RECIST v1.1 or death due to any cause.
Prostate-Specific Antigen 50% response rate (PSA50 rate)
PSA50 rate is defined as the proportion of patients who achieve a ≥50% decrease in prostate-specific antigen (PSA) from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks later without any PSA progression in between.
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