Safety and Efficacy of MIW815 (ADU-S100) + / - Ipilimumab in Patients With Advanced / Metastatic Solid Tumors or Lymphomas

Status: Active

Description

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection as a single agent and in combination with ipilimumab.

Eligibility Criteria

Inclusion Criteria

  • ECOG ≤ 1
  • Willing to undergo tumor biopsies from injected and distal lesions
  • Must have two biopsy accessible lesions:
  • * one lesion must be ≥10 mm and <100 mm in longest diameter, accessible for repeated intratumoral (IT) injection and accessible for baseline and on-treatment biopsies.
  • a second (distal) lesion must be accessible for baseline and on-treatment biopsy and must be distinct from the injected lesion.
  • tumors encasing major vascular structures (i.e., carotid artery or tumors close to other vital organs), are not considered appropriate

Exclusion Criteria

  • Patients who require local palliative measures such as XRT or surgery
  • Symptomatic or untreated leptomeningeal disease.
  • Presence of symptomatic central nervous system (CNS) metastases
  • Impaired cardiac function or clinically significant cardiac disease
  • Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
  • Active infection requiring systemic antibiotic therapy.
  • Known history of Human Immunodeficiency Virus (HIV) infection.
  • Active Epstein-Barr virus (EBV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Malignant disease, other than that being treated in this study.

Locations & Contacts

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Contact: Frank Stephen Hodi
Phone: 866-790-4500
Dana-Farber Cancer Institute
Status: Active
Contact: Frank Stephen Hodi
Phone: 866-790-4500
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Aduro Biotech, Inc.

Trial IDs

Primary ID ADU-CL-07
Secondary IDs NCI-2016-00420
Clinicaltrials.gov ID NCT02675439