🏛️ Verified NIH Record • Updated 2026-05-12

A Study of DS5361b in Participants With Advanced Solid Tumors (NCT07182591)

A Phase 1, Open-label, Multicenter, First-in-Human Trial of DS5361b in Participants With Advanced Solid Tumors

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Daiichi Sankyo

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

This study aims to assess the safety, tolerability, and preliminary efficacy and to determine the MTD of DS5361b in monotherapy and combination with pembrolizumab in participants with advanced or metastatic solid tumors.

Who can join: Review the eligibility criteria below.

Location: Research Site — Sarasota, Florida

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)

  • Research Site — Sarasota, Florida
  • Research Site — Providence, Rhode Island
  • Research Site — Irving, Texas
  • Research Site — San Antonio, Texas
  • Research Site — Fairfax, Virginia
  • Research Site — Kashiwa,
  • Research Site — Kōtoku,

📞 Contact the Study Coordinator

Phone: (908) 992-6400

Email: CTRinfo_us@daiichisankyo.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 ↗