Phase 1 Study of Oral SHY-ONC6 Proteasome Inhibitor in Adults with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are conducting a Phase 1, first-in-human, open-label study to assess the safety, tolerability, pharmacokinetics, and initial anti-tumor effects of SHY-ONC6 in adults with advanced or metastatic solid tumors who have either progressed on or cannot tolerate standard treatments. This study includes participants with various tumor types such as breast, colon, gastric, lung, pancreatic, prostate, and soft tissue sarcomas. The study aims to find a safe and recommended dose for further research. Participants receive SHY-ONC6 orally once daily in 21-day cycles. The study has two parts Phase 1a involves dose escalation using accelerated titration and Bayesian optimal interval methods to determine the maximum tolerated dose. Phase 1b evaluates disease-specific groups at the recommended Phase 2 dose identified in Phase 1a. Treatment continues until withdrawal, unacceptable toxicity, or disease progression. During the study, participants undergo multiple assessments including evaluation of dose-limiting toxicities, adverse events, and pharmacokinetic measures such as plasma drug concentration over time. Tumor response and overall survival are monitored for up to 18 months. Safety follow-up extends 30 days beyond the last dose. Participants are closely monitored through regular visits and tests to understand the drugs effects and safety profile.

A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors