🏛️ Verified NIH Record • Updated 2026-07-28

Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers (NCT06562192)

Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

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

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety, dosimetry and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

Who can join: Review the eligibility criteria below.

Location: Uni of Alabama at Birmingham — Birmingham, Alabama

Age range: 18 Years to 100 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 (29 Sites)

Showing the first 25 of 29 sites.

  • Uni of Alabama at Birmingham — Birmingham, Alabama
  • University of California LA — Los Angeles, California
  • Stanford University Medical Center — Palo Alto, California
  • Mayo Clinic Jacksonville — Jacksonville, Florida
  • Massachusetts General Hospital — Boston, Massachusetts
  • BAMF Health — Grand Rapids, Michigan
  • Mayo Clinic Rochester — Rochester, Minnesota
  • Uni Of TX MD Anderson Cancer Cntr — Houston, Texas
  • University Of Washington — Seattle, Washington
  • Novartis Investigative Site — Brussels,
  • Novartis Investigative Site — Toronto, Ontario
  • Novartis Investigative Site — Montreal, Quebec
  • Novartis Investigative Site — Montreal, Quebec
  • Novartis Investigative Site — Bron,
  • Novartis Investigative Site — Villejuif,
  • Novartis Investigative Site — Cologne, North Rhine-Westphalia
  • Novartis Investigative Site — Essen,
  • Novartis Investigative Site — München,
  • Novartis Investigative Site — Rostock,
  • Novartis Investigative Site — Tel Aviv,
  • Novartis Investigative Site — Milan, MI
  • Novartis Investigative Site — Reggio Emilia, RE
  • Novartis Investigative Site — Nijmegen, Gelderland
  • Novartis Investigative Site — Utrecht,
  • Novartis Investigative Site — Barcelona,

📞 Contact the Study Coordinator

Phone: (888) 669-6682

Email: novartis.email@novartis.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 ↗