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NCT07570979
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 208
Sponsor: Novartis Pharmaceuticals
Location: Mass General Hospital Boston Massachusetts
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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 (\
Source: ClinicalTrials.gov (NCT07570979). StuddyBuddy aggregates publicly available trial information.