🏛️ Verified NIH Record • Updated 2026-06-09

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors (NCT05283330)

A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Orano Med Theranostics, SAS

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

A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors

Who can join: Review the eligibility criteria below.

Location: Northwestern University Robert H Lurie Medical Research — Chicago, Illinois

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 (8 Sites)

  • Northwestern University Robert H Lurie Medical Research — Chicago, Illinois
  • University of Iowa Health Care — Iowa City, Iowa
  • UK Markey Cancer Center — Lexington, Kentucky
  • Advanced Molecular Imaging and Therapy — Glen Burnie, Maryland
  • United Theranostics - Chesapeake — Glen Burnie, Maryland
  • Nebraska Cancer Specialists (Midwest Cancer Center - Legacy) — Omaha, Nebraska
  • XCancer Omaha / Urology Cancer Center — Omaha, Nebraska
  • University of Pittsburg Medical Center (UPCM) — Pittsburgh, Pennsylvania

📞 Contact the Study Coordinator

Phone: (469) 638-0744

Email: clinicaltrials@oranomed.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.

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💡 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 ↗