A Phase I Study of MEDI5395 and Durvalumab Immunotherapy in People with Advanced Solid Tumors

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Full Title

An Open-label Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI5395 in Combination with Durvalumab in Subjects with Select Advanced Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug MEDI5395 that can be given safely with durvalumab in patients with advanced solid tumors. Both drugs are immunotherapies. They are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a recurrent or metastatic solid tumor that has continued to grow despite prior treatment for advanced cancer.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please call 646-888-4593.

Protocol

20-048

Phase

I

Investigator

Co-Investigators