TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

Trial Details

NCT ID
NCT07190300
Phase
PHASE1 / PHASE2
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • Tulmimetostat
  • Darolutamide
  • Abiraterone
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Westwood, Kansas, United States|39.04056,-94.6169
  • Wichita, Kansas, United States|37.69224,-97.33754
  • Durham, North Carolina, United States|35.99403,-78.89862

Key Eligibility Criteria

  • Adult men ≥ 18 years old with de novo or recurrent mHSPC (without neuroendocrine or small cell features). The tumor lesion(s) may be located in the…
  • Participants must have castrate levels of testosterone, i.e., ≤ 50 ng/dL (≤ 1.7 nM).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • Adequate bone marrow and organ function

For full eligibility, visit ClinicalTrials.gov.

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