A Phase I Study of MEDI3617 in Patients with Advanced Solid Tumors

Protocol
11-052
Full Title
A Phase 1/1b, Multicenter, Open-label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617, a Human Monoclonal Antibody Directed Against ANG2, as a Single Agent or in Combination Therapy in Adult Subjects with Advanced Solid Tumors
Phase
I
Purpose

Tumors need a blood supply in order to grow and spread. The development of these blood vessels is called angiogenesis. One way of controlling cancer is to inhibit angiogenesis.

MEDI3617 is an antibody (a type of protein that is part of the immune system) which binds to proteins involved in angiogenesis called angiopoietin 1 and angiopoietin 2. Laboratory studies suggest that MEDI3617 can inhibit new blood vessel formation in tumors, thereby “starving” the tumor of the nutrients and oxygen it requires to continue to grow.

In this study, researchers want to find the highest dose of MEDI3617 that can be given safely in patients with advanced solid tumors that continue to grow despite standard therapy or for which no standard therapy exists. This is the “dose-escalation” part of the study. In a second part of the study, MEDI3617 will be evaluated specifically in patients with advanced non-small cell lung cancer or advanced colorectal cancer that continues to grow despite therapy.

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 continues to grow despite standard therapy or for which no standard therapy exists (for the dose-escalation phase) or advanced non-small lung cancer or advanced colorectal cancer that continues to grow despite standard therapy or for which no standard therapy exists (for the expansion phase).
  • At least 4 weeks must have passed since completion of prior therapies (6 weeks since receipt of bevacizumab or other anti-angiogenic drugs that target the vascular endothelial growth factor) and entry into the study.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Naiyer Rizvi at 646-888-4204.

Disease(s)
Colorectal Cancer
Lung Cancer
Lung Cancer, Non-Small Cell
Lung Cancer, Non-Small Cell: Lung Adenocarcinoma
Locations

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