A Phase I Study of MEDI1191 plus Durvalumab to Treat Advanced Solid Tumors

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Full Title

A Phase 1, Open-label, Dose-escalation and Expansion Study of MEDI1191 Administered Intratumorally as Monotherapy and in Combination with Durvalumab in Subjects with Advanced Solid Tumors

Purpose

The purpose of this study is to find the optimal dose of the investigational drug MEDI1191 to be given with durvalumab in patients with advanced solid tumors that came back or spread despite treatment. Patients will receive MEDI1191 followed by durvalumab, or both medications at the same time. MEDI1191 is injected directly into a tumor (intratumoral injection) and durvalumab is 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 an advanced solid tumor that came back or spread despite treatment.
  • Patients must have a tumor that is amenable to intratumoral injection (such as a superficial metastasis that is easily accessible for injection).
  • 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. Matthew Hellmann at 646-888-4863.

Protocol

19-235

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators