FDA Clears Investigational New Drug Application for R-5780 in Solid Tumors
Source: Cancer Network, January 2025
The RISE R-5780-01 trial will evaluate the safety and tolerability of R-5780 in patients with melanoma, basal cell carcinoma, or squamous cell carcinoma.
The FDA has accepted an investigational new drug application for R-5780, a precision-directed synthetic biology medicine that engages immune pathways to support robust anti-tumor T cell responses, in the treatment of patients with solid tumors, according to a press release from the developer, Rise Therapeutics.
Next steps will see to the beginning of the multi-dose phase 1 RISE R-5780-01 trial (NCT06398418) evaluating the safety and tolerability of R-5780 in patients currently receiving PD-1 pathway checkpoint inhibitors for solid tumors.