This is a Phase 1A/1B clinical trial designed to assess the safety, pharmacokinetics, and clinical activity of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care therapy in Non-Small Cell Lung Cancer. In Phase IA, patients with solid tumors that are refractory to available therapies will be recruited. Cancer patients enrolled in the trial will receive increasing doses of ONC-392 based on his/her tolerance to the drug and anti-tumor effect of the immunotherapy.
ONC-392 was developed based on decades of fundamental research on CTLA-4 biology and immunotherapy by OncoImmune’s Founders, Drs. Yang Liu and Pan Zheng who proposed a new theory to improve both the efficacy and safety of immunotherapy drugs. Unlike other anti-CTLA-4 antibodies that induce CTLA-4 degradation and thus weaken immune tolerance and cause immunotherapy-associated adverse events (irAE), ONC-392 preserves the CTLA-4 immune checkpoint for safer and more effective immunotherapy.
OncoImmune is enormously grateful to Dr. Tianhong Li, a leading medical Oncologist and associate professor at UC Davis, for her wealth of experience in immunotherapy, especially in lung cancer, and her colleagues at the UC Davis Comprehensive Cancer Center for being the first site to open the trial. “CTLA-4 is an important but challenging immunotherapeutic target. This study is important as we look at this new generation anti-CTLA-4 antibody, which potentially could benefit all cancer patients who are candidates for cancer immunotherapy,” said Dr. Li.