A Study of SHY-ONC6, a Novel Proteasome Inhibitor, in Adults With Advanced or Metastatic Solid Tumors (NCT07705334)
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 1, first-in-human (FIH), open-label, multicenter study designed to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SHY-ONC6 in participants with advanced or metastatic solid tumors who have progressed on or are intolerant to standard therapies. The study will consist of 2 parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (15 items).
Location: HonorHealth Research Institute — Scottsdale, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- High-risk cardiovascular disease.
- Concurrent anti-cancer treatment.
- Active infection requiring systemic treatment within 2 weeks pre-dose.
- History of another malignancy (with standard exceptions for in situ disease, non-melanoma skin cancers, and remission ≥2 years).
- Active HBV (HBV-DNA \>ULN), HCV (HCV-RNA \>ULN), or HIV (well-controlled HIV with CD4 ≥350 cells/µL and undetectable viral load permitted); AIDS-defining opportunistic infection within 12 months.
- Compromised pulmonary function within 6 months pre-dose .
- Pregnancy or breastfeeding.
- Recent radiotherapy, systemic anti-tumor therapy, other investigational therapy without appropriate washout.
- Major surgery ≤4 weeks pre-dose.
- Unable to swallow tablets or conditions affecting GI absorption.
- Any medical or psychiatric disorders affecting compliance and/or interpretation of study results.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- HonorHealth Research Institute — Scottsdale, Arizona
- SCRI at HCA HealthONE — Denver, Colorado
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- NEXT Oncology — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.