A Phase I Study of ONC-392 Immunotherapy in People with Advanced Pancreatic Cancer

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Full 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

Purpose

The purpose of this study is to assess the safety of the investigational immunotherapy drug ONC-392 in people with pancreatic cancer that has continued to grow despite treatment. ONC-392 attaches to and blocks a protein called CTLA-4, enabling immune cells to detect and destroy cancer cells. Researchers think that ONC-392 will work against pancreatic cancer because pancreatic cancers have a high number of cells with the CTLA-4 protein. OCN-392 is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants should have advanced pancreatic cancer that has continued to grow despite prior treatment.
  • At least 3-4 weeks must pass since the completion of previous therapies and receipt of ONC-392.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Kenneth Yu at 646-888-4188.

Protocol

22-034

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT04140526