Condition: Solid Tumor · Sponsor: Novartis Pharmaceuticals
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.
This description comes directly from the study's public registry record.
Novartis Pharmaceuticals · 1-888-689-6682 · novartis.email@novartis.com
Novartis Pharmaceuticals · +41613241111 · novartis.email@novartis.com
Always discuss trial participation with your own doctor first.
| UAB Comprehensive Cancer Center | Birmingham, Alabama, United States | Recruiting |
| City of Hope | Duarte, California, United States | Recruiting |
| Hoag Hospital Irvine | Irvine, California, United States | Recruiting |
| University of California Los Angeles (UCLA) | Los Angeles, California, United States | Recruiting |
| UCSF Medical Center | San Francisco, California, United States | Recruiting |
| Mayo Clinic | Jacksonville, Florida, United States | Recruiting |
| University of Miami Hospital and Clinics | Miami, Florida, United States | Recruiting |
| University of Chicago Medical Center | Chicago, Illinois, United States | Recruiting |
| University of Iowa Hospitals and Clinics | Iowa City, Iowa, United States | Recruiting |
| Karmanos Cancer Institute | Detroit, Michigan, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| Saint Louis University Hospital | St Louis, Missouri, United States | Recruiting |
+ 29 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT04939610