Study of a GITR Agonistic Antibody as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Clinical Trial Title

A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

National Clinical Trial Number:

NCT03799003

Clinical Trial Protocol Description:

The purpose of this study is to determine at what dose the study drug (ASP1951 alone or ASP1951 plus pembrolizumab) is safe and tolerated and how it is processed in the blood of participants with tumors that cannot be removed (unresectable) or has spread (metastasized) to a different part of the body. When the safe dose is identified, it will be used to evaluate if the study drug treatment causes tumors to shrink in participants. During this period, the study drug will be continuously assessed to determine if it is safe and tolerated by participants taking it.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are at least 18 years of age of older.
  • Have locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy.
  • Have an ECOG Performance Status of 0, 1 or 2.
  • Complete any radiotherapy (including stereotactic radiosurgery) at least 2 weeks prior to study drug administration.

You will be excluded from the study if any of the following criteria apply to you:

  • Weigh < 45 kg (under 99 lbs).
  • Have been given a systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration.
  • Have leptomeningeal disease (brain tumors) as a manifestation of the current malignancy.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Study Details

Clinical Trial Investigator

Michael Jelinek, MD

Contact Information

Rush Cancer Center Clinical Trials Office