NEW YORK – Ratio Therapeutics on Wednesday said that it began a Phase I trial of the fibroblast activation protein-alpha (FAP)-targeted radiopharmaceutical Cu-64-labeled RTX-1363S in healthy volunteers.
FAP is expressed in cancer-associated fibroblasts in nearly all epithelial-derived cancers, while expressing at low abundance in normal tissues. The Boston-based company is developing RTX-1363S as a tumor imaging agent for a wide variety of cancers in collaboration with Lantheus and PharmaLogic.
In the first trial, up to six participants will be evaluated for biodistribution, pharmacokinetics, and dosimetry following a single injection of [Cu-64]-labeled RTX-1363S. Results of the study will be used to guide further development of the product as a FAP-targeted tumor imaging agent.
"Cancer-associated fibroblasts selectively expressing FAP comprise up to 90 percent of the tumor mass in highly desmoplastic cancers including pancreatic, breast, and colorectal," Ratio President and CSO John Babich said in a statement. "RTX-1363S has the potential to transform the way we detect and monitor various epithelial-derived cancers."