A Phase I Study of MEDI9253 and Durvalumab in People with Advanced or Metastatic 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 MEDI9253, a Recombinant Newcastle Disease Virus Encoding Interleukin-12, in Combination with Durvalumab in Participants with Select Advanced/Metastatic Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug MEDI9253 that can be given in combination with durvalumab in patients with advanced or metastatic colorectal cancer, renal cell carcinoma, or melanoma. Both drugs are immunotherapies and 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 advanced or metastatic colorectal cancer, renal cell carcinoma with a clear cell component, or melanoma that persists despite prior therapy.
  • Patients must recover from the serious side effects of previous treatments before receiving the study treatment.
  • 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 contact Dr. Dmitriy Zamarin at 646-888-4593.

Protocol

20-497

Phase

I

Investigator