NEW YORK – Ideaya Biosciences on Monday said it will begin evaluating the investigational PARG inhibitor IDE161 in a Phase I clinical trial involving patients with solid tumors harboring homologous recombination deficiencies including those with estrogen receptor-positive, HER2-negative breast cancer.
The news of the first-in-human trial comes after the US Food and Drug Administration cleared Ideaya's investigational new drug application for IDE161, allowing the study to proceed.
The trial, slated to begin in Q1 of this year, will enroll patients with multiple tumor types including individuals with breast and ovarian tumors characterized by mutations in BRCA1, BRCA2, and other genes involved in homologous recombination repair. Ideaya aims to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties, and preliminary efficacy of IDE161 as a monotherapy.
IDE161 is designed to inhibit PARG, which shares a pathway with PARP. According to South San Francisco, California-based Ideaya, the agent has led to tumor regressions in PARP inhibitor-refractory preclinical models.