An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)

This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).

Trial Details

NCT ID
NCT07206056
Phase
PHASE1 / PHASE2
Sponsor
Novartis Pharmaceuticals
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Tulmimetostat DL1 QD
  • Tulmimetostat DL2 QD
  • Tulmimetostat DL3 QD
  • Tulmimetostat Doses 1 or 2 QD
  • Tulmimetostat RP2D QD
  • JSB462 Dose 1 QD
Locations (sample)
  • Denver, Colorado, United States|39.73915,-104.9847
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Wichita, Kansas, United States|37.69224,-97.33754
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Participant is an adult man ≥ 18 years of age.
  • Participant must have histologically and/or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell features (c…
  • Participant must have ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to start o…
  • Participant must have progressive mCRPC.

For full eligibility, visit ClinicalTrials.gov.

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