Condition: Advanced Solid Tumors & Non-Small Cell Lung Cancer (NSCLC)
STUDY TITLE:
Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination
with Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open-label Phase IA/IB/II
Study
DISEASE: Advanced Solid Tumors and Non-Small Cell Lung Cancer (NSCLC)
SUMMARY:
This study is to determine whether the study drug, ONC-392, either given alone or in combination with a standard of care drug is safe and effective in cancer treatment. Blood tests will be done to determine how the drug in absorbed and processed in the body.
There is a protein found on T-cells (a type of immune cell) that helps keep the body’s immune responses in check. This CTLA-4 protein receptor found on the surface of a cell interacts with another protein called B7-1 (CD80) and B7-2 (CD86) and keeps the T-cell from killing other cells, including cancer cells. ONC-392 is a highly selective antibody against CTLA-4.
ONC-392 is an antibody drug that stimulates and regulates the immune system to treat cancer. This type of treatment is called Immunotherapy. The study drug binds to CTLA-4 and reduces the regulatory immune cells and let normal immune cells get into the tumor mass to fight cancer.
In Part A of the study, subjects will receive ONC-392 alone. In Part B subjects will receive ONC-392 plus Keytruda (pembrolizumab). Pembrolizumab has been approved for certain types of cancers including NSCLC. However, the combination of ONC-.392 and pembrolizumab is considered investigational.
If you would like more information please call PCSRI at 717-334-4033 ext 131, 148, or 149, or email research@pcsri.com.
