Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC

Status:	Active, not recruiting
Conditions:	Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	12/8/2018
Start Date:	May 2016
End Date:	May 2019

A Phase 1/2 Study of HDAC Inhibitor, Mocetinostat, in Combination With PD-L1 Inhibitor, Durvalumab, in Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer

Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a
human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or
PD-L1). Durvalumab is also known as a checkpoint inhibitor.

This study is evaluating the combination regimen of mocetinostat and durvalumab in subjects
with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.

Patients eligible for this study may have previously received treatment with a checkpoint
inhibitor.

The treatment regimen will begin with a 7-Day Lead-in Period of mocetinostat alone followed
by start of the combination regimen of mocetinostat and durvalumab. The Recommended Phase 2
Dose of mocetinostat will be established in the Phase 1 dose escalation segment, followed by
evaluation of the clinical activity of the combination regimen in Phase 2.

Inclusion Criteria:

- Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC

- Not amenable to treatment with curative intent

- Adequate bone marrow and organ function

Exclusion Criteria:

- Impaired heart function

- Uncontrolled tumor in the brain

- Other active cancer

We found this trial at

sites

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

675 N Saint Clair St # 21-100
Chicago, Illinois 60611

(312) 695-1156