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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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 5 → 9 locations Eligibility criteria expanded, about 13 words · Study description revised Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Study description revised
  2. Study sites: 3 to 5v4
  3. Study sites: 2 to 3v3
  4. Start date changed from estimate of May 26, 2026 to May 25, 2026v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Novartis
555 trials monitored
See 31 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
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 Number NCT07570979
Lead Sponsor Novartis Pharmaceuticals
Conditions Metastatic Castration-resistant Prostate Cancer (mCRPC)
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov