FXX489 / Novartis - LARVOL DELTA

FXX489, a FAP targeting ligand with best-in-class potential for radioligand therapy (AACR 2025) - "There is no abstract associated with this presentation."

Oncology

Phase I open-label, multi-center study to evaluate the safety, tolerability, dosimetry, and preliminary activity of FXX489 ([177Lu]Lu-NNS309) in patients with pancreatic, lung, breast and colorectal cancers (AACR 2025) - P1 | "The study is currently enrolling in the dose escalation part."

Clinical • First-in-human • P1 data • Breast Cancer • Colorectal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Triple Negative Breast Cancer • CAFs • FAP • HER-2

Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases. (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Yi Tian | Not yet recruiting ➔ Recruiting | N=80 ➔ 30

Enrollment change • Enrollment open • Oncology

FXX489, a FAP targeting ligand with best-in-class potential for radioligand therapy (AACR 2025) - P1 | "Optimization was enabled by the co-crystal structure and was focusing on maximizing compound affinity and proteolytic stability. FXX489 binds to both human and mouse FAP with the affinity < 10 pM; shows exquisite selectivity over other proteases (such as DPP4); is stable in blood and plasma."

Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CAFs • FAP

Application of ⁶⁸Ga-FXX489 (NNS309) PET/CT Imaging in Diagnosis of Tumor Diseases. (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Yi Tian

New P1 trial • Oncology

Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers (clinicaltrials.gov) - P1 | N=124 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P1 trial • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer