Phase 1 Dose-Escalation Study of KTX-2001 (an NSD2 Inhibitor) Alone and in Combination with Darolutamide for Metastatic Castration-Resistant Prostate Cancer

Brief description of study

This is a multicenter, open-label Phase 1 study in participants with metastatic castration-resistant prostate cancer (mCRPC) to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of KTX-2001 monotherapy (Part A) and KTX-2001 in combination with darolutamide 600 mg twice daily (BID) (Part B), and to establish a recommended Phase 2 dose(s) of KTX-2001 for future study.


Clinical Study Identifier: s25-01058
ClinicalTrials.gov Identifier: NCT07103018
Principal Investigator: David R. Wise.
Other Investigators: Minas Platon Economides, Victor Ricardo Adorno Febles.


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