PCCTC-managed Phase 1 Study of K36’s Novel NSD2 Inhibitor KTX-2001 Activated

We’re excited to announce the activation of San Antonio, Texas’ USA Clinical Trials as the first site for the PCCTC-managed phase 1 clinical study of K36’s novel NSD2 inhibitor KTX-2001 (STRIKE-001; NCT07103018). STRIKE-001 is the first-in-human clinical trial testing KTX-2001 alone and with darolutamide in participants with metastatic castration-resistant prostate cancer (mCRPC). The study aims to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of KTX-2001 monotherapy and KTX-2001 in combination with darolutamide (NUBEQA), and to establish a recommended Phase 2 dose(s) (RP2D) of KTX-2001 for future study.  

The PCCTC’s rapid activation of STRIKE-001—from regulatory submission to site initiation—showcases our commitment to operational excellence and collaborative execution. CEO Jake Vinson added, “This milestone reflects the precision and agility that define our operations—delivering for patients and partners with unmatched speed and quality,” 

Our sincere thanks to K36 and Dr. Jose de La Cerda III and his team at USA Clinical Trials for independent coverage analysis and leadership in setting a new standard for rapid collaboration and startup. 

To learn more about the study visit https://clinicaltrials.gov/study/NCT07103018