Last updated on September 2017

Safety Study of SEA-CD40 in Cancer Patients


Brief description of study

This study will examine the safety profile of SEA-CD40 given alone and in combination with pembrolizumab. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

Detailed Study Description

The study will be conducted in the following parts: Part A: Monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated. Part B: Monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the SEA-CD40 monotherapy MTD and/or OBD determined in Part A. Part C: Monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated. Part D: Monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the SEA-CD40 monotherapy MTD and/or OBD determined in Part C. Part E: Combination therapy dose-regimen finding for solid tumors -- SEA-CD40 dose-escalation to define the MTD and/or the OBD regimen to be administered in combination with standard approved dose of pembrolizumab in patients with solid tumors. Part F: Combination therapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with SEA-CD40 and pembrolizumab combination therapy; doses of SEA-CD40 will be at or below the MTD and/or OBD determined in Part E.

Clinical Study Identifier: NCT02376699

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Amitkumar Mehta, MD

University of Alabama at Birmingham
Birmingham, AL United States
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Michael Gordon, MD

HonorHealth Scottsdale Shea Medical Center
Scottsdale, AZ United States
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Monica Mita, MD

Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles, CA United States
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Monica Mita, MD

Angeles Clinic and Research Institute, The
Santa Monica, CA United States
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Thomas Gajewski, MD, PhD

University of Chicago
Chicago, IL United States
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David Smith, MD

University of Michigan Comprehensive Cancer Center
Ann Arbor, MI United States
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Svetomir Markovic, MD

Mayo Clinic Minnesota
Rochester, MN United States
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Martin Gutierrez, MD

Hackensack University Medical Center
Hackensack, NJ United States
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Olivier Rixe

University of New Mexico Cancer Center
Albuquerque, NM United States
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Sanjay Goel, MD

Montefiore Medical Center
The Bronx, NY United States
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Juneko Grilley-Olson, MD

UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, NC United States
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Brendan Curti, MD

Providence Portland Medical Center
Portland, OR United States
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Yasuhiro Oki, MD

MD Anderson Cancer Center / University of Texas
Houston, TX United States
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Andrew Coveler, MD

Seattle Cancer Care Alliance / University of Washington
Seattle, WA United States
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