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A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors

Trial Status: Active

Study D7880C00001 is a first-in-human (FIH), Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of MEDI9253 in combination with durvalumab in adult participants with select advanced / metastatic solid tumors.

Inclusion Criteria

  • Inclusion Criteria: 1. Participant must be at least 18 years old at signing of informed consent. 2. Body weight > 35 kg at screening Exclusion Criteria: 1 Primary central nervous system (CNS) disease is excluded, as well as untreated or uncontrolled metastatic CNS involvement, leptomeningeal disease, or cord compression. NOTE: CNS disease that has been treated and stable/controlled for at least 3 months is permitted. Participants with CNS disease controlled via systemic steroids are not permitted.

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

Up to approximately 192 participants may be assigned to study intervention in the study

across approximately 30 sites globally.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D7880C00001
  • Secondary IDs NCI-2020-13138
  • Clinicaltrials.gov ID NCT04613492