NEW YORK – Incendia Therapeutics on Tuesday said it has started enrolling patients in a Phase Ic trial of its DDR1 inhibitor PRTH-101 for the treatment of advanced or metastatic solid tumors.
In the Phase I trial, Incendia is enrolling up to 270 patients and assessing PRTH-101's safety and tolerability, dosing, and anti-tumor activity. In the Phase Ic portion, the Cambridge, Massachusetts-based firm will evaluate PRTH-101 as a monotherapy and in combination with Merck's checkpoint inhibitor Keytruda (pembrolizumab). Researchers in the trial are also exploring expression of DDR1 and pathway-related proteins as predictive biomarkers for identifying best responders to treatment.
"In our Phase Ia and Ib studies, we were able to select an optimal dose and identify potential biomarkers to carry forward," Irena Webster, senior VP of development and operations at Incendia, said in a statement. "The data from this study will inform the design of the Phase II/III program, for which planning and global feasibility are currently underway."
PRTH-101's target, DDR1, is a collagen binding protein and kinase present on epithelial cells. The drug is designed to disable DDR1, which can disrupt a tumor's collagen alignment and allow immune cell access into the tumor core. Tumor types that express high levels of DDR1-associated collagen barriers include thymic, colorectal, pancreatic, ovarian, and non-small cell lung cancer, and glioma, according to Incendia.