Phase 2 Trial of Tomivosertib Begins Dosing Advanced Castration-resistant PC Patients

Phase 2 Trial of Tomivosertib Begins Dosing Advanced Castration-resistant PC Patients
A Phase 2 clinical trial evaluating eFFECTOR Therapeutics' investigational therapy tomivosertib (eFT508), for men with advanced castrate-resistant prostate cancer (CRPC) who failed to respond to androgen receptor signaling (ARS) inhibitors, has begun dosing patients. The trial (NCT03690141), currently recruiting participants, will evaluate the safety, tolerability and antitumor activity of tomivosertib in patients whose disease progressed while on treatment with the ARS inhibitors Zytiga (abiraterone acetate) or Xtandi (enzalutamide). Thirty patients will be enrolled across 10 clinical sites in the U.S. Participants will receive oral capsules of tomivosertib, administered twice a day for 52 weeks. The study primarily aims to assess tomivosertib's anti-tumor response, defined by either a 50 percent or larger reduction in prostate-specific antigen (PSA) levels, or objective response measured by iRECIST, a response evaluation criteria for solid tumors, with interim and final analyses at eight and 12 months after the last patient commenced treatment. Secondary measures include time to disease progression or death, overall survival, and safety. The behavior of tomivosertib once inside the body — absorption, metabolism, excretion — also will be assessed. In previous clinical trials, tomivosertib was found safe, well-tolerated, and with a long-term anti-tumor activity in patients with solid tumors or lymphomas whose disease pro
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