A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (NCT04939610)
LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients With an Advanced Solid Tumor
🩺 Plain-English Summary (8th-Grade Level)
Fibroblast activation protein (FAP) is a cell surface protein that is highly expressed on the surface of cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers, whereas limited expression of FAP is observed in normal tissues. In some cancers of mesenchymal origin, notably sarcoma and mesothelioma, FAP expression has also been observed on the tumor cells themselves. Given the restricted expression profile, FAP is a promising target for peptide-targeted radionuclide imaging and therapeutic agents. Phase 1 of this study is designed to evaluate the safety and establish the recommended intravenous (IV) Phase 2 dose (RP2D) for \[177Lu\]Lu FAP 2286 monotherapy in participants with FAP expressing solid tumors. Phase 2 is designed to evaluate the safety and efficacy of \[177Lu\]Lu FAP 2286 as monotherapy in participants with pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and breast cancer (BC) and in combination with chemotherapy in participants with untreated PDAC or relapsed NSCLC. Participants in both Phase 1 and 2 will be selected for treatment with \[177Lu\]Lu FAP 2286 based on \[68Ga\]Ga FAP 2286 imaging for determining tumor FAP expression.
Who can join: Review the eligibility criteria below.
Location: UAB Comprehensive Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (41 Sites)
Showing the first 25 of 41 sites.
- UAB Comprehensive Cancer Center — Birmingham, Alabama
- City of Hope — Duarte, California
- Hoag Hospital Irvine — Irvine, California
- University of California Los Angeles (UCLA) — Los Angeles, California
- UCSF Medical Center — San Francisco, California
- Mayo Clinic — Jacksonville, Florida
- University of Miami Hospital and Clinics — Miami, Florida
- University of Chicago Medical Center — Chicago, Illinois
- University of Iowa Hospitals and Clinics — Iowa City, Iowa
- Karmanos Cancer Institute — Detroit, Michigan
- Mayo Clinic — Rochester, Minnesota
- Saint Louis University Hospital — St Louis, Missouri
- Columbia University Medical Center — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- UNC Hospitals — Chapel Hill, North Carolina
- Oregon Health and Science University — Portland, Oregon
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- University of Texas MD Anderson Cancer Center — Houston, Texas
- Univ of Utah, Huntsman Cancer Institute — Salt Lake City, Utah
- Fred Hutchinson Cancer Center — Seattle, Washington
- Novartis Investigative Site — Adelaide, South Australia
- Novartis Investigative Site — Melbourne, Victoria
- Novartis Investigative Site — Melbourne, Victoria
- Novartis Investigator Site — Murdoch, Western Australia
- Novartis Investigating Site — London, Ontario
📞 Contact the Study Coordinator
Phone: (888) 689-6682
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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.