🏛️ Verified NIH Record • Updated 2025-06-27

A Study to Assess Safety and Efficacy of SOT201 in Patients With Advanced/Metastatic Cancer (NCT06163391)

A Multicenter, Open-label, Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of SOT201 in Patients With Advanced/Metastatic Solid Tumors

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: SOTIO Biotech AG

🩺 Plain-English Summary (8th-Grade Level)

This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined

Who can join: Review the eligibility criteria below.

Location: MD Anderson Cancer Center — Houston, Texas

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (7 Sites)

  • MD Anderson Cancer Center — Houston, Texas
  • Universitair Ziekenhuis Antwerpen (UZA) — Edegem, Antwerp
  • Institut Jules Bordet — Anderlecht, Brussels Capital
  • Masarykův Onkologický Ústav — Brno,
  • Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika — Olomouc,
  • Institut Gustave Roussy — Paris,
  • Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO) — Barcelona,

📞 Contact the Study Coordinator

Phone: (+420) 2241 74448

Email: kapsa@sotio.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗