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

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.

Trial Details

NCT ID
NCT07570979
Phase
PHASE1
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • INR731
  • Enzalutamide
  • Abiraterone
  • Androgen deprivation therapy (ADT)
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Dallas, Texas, United States|32.78306,-96.80667
  • Melbourne, Victoria, Australia|-37.814,144.96332
  • Toronto, Ontario, Canada|43.65333,-79.38389
  • Montreal, Quebec, Canada|45.50884,-73.58781

Key Eligibility 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 (neuroendo…
  • At least 1 metastatic lesion (according to local radiology assessment by the investigator) present on baseline CT, MRI, or bone scan imaging obtain…
  • Patients must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L).

For full eligibility, visit ClinicalTrials.gov.

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