Incendia Therapeutics has commenced a Phase Ic clinical trial evaluating PRTH-101, a first-in-class DDR1 inhibitor, in patients with advanced or metastatic solid tumors. The trial, an open-label study, is designed to assess the safety, tolerability, and anti-tumor activity of PRTH-101 both as a single agent and in combination with pembrolizumab, a checkpoint inhibitor.
The Phase Ic trial plans to enroll up to 270 patients across multiple sites in the United States. The study incorporates a dose-escalation phase to determine the optimal dosing regimen for subsequent Phase II clinical trials. Furthermore, the trial will explore the potential of DDR1 and related proteins as predictive biomarkers for patient response to PRTH-101.
Rationale for PRTH-101
PRTH-101 is a humanized antibody designed to selectively target DDR1, a receptor tyrosine kinase implicated in tumor growth, invasion, and metastasis. DDR1 is often overexpressed in various solid tumors, making it an attractive therapeutic target. Preclinical studies have suggested that PRTH-101 can disrupt tumor defenses and enhance the effectiveness of checkpoint inhibitors, providing a rationale for its combination with pembrolizumab.
Biomarker Exploration and Future Development
According to Incendia Therapeutics, data from the Phase Ia and Ib studies helped in selecting an optimal dose and identifying potential biomarkers. Irena Webster, Senior Vice President, Development and Operations at Incendia Therapeutics, stated that the data from the current study will inform the design of the Phase II/III program, for which planning and global feasibility assessments are underway.
Dr. Joseph Paul Eder, CMO of Incendia Therapeutics, highlighted the consistent safety profile of PRTH-101 as a single agent and in combination with pembrolizumab. He added that the focus will now be on tumor types that have demonstrated signs of clinical activity and patient benefits.
Incendia's Approach to Tumor Microenvironment
Incendia Therapeutics is focused on developing therapies that modulate the tumor microenvironment to enhance anti-tumor immunity and overcome resistance mechanisms. The development of PRTH-101 reflects this approach, aiming to target DDR1 and disrupt its role in promoting tumor progression.
