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

Stopped early · Phase 1

Conditions studied: Advanced/Metastatic Solid Tumors or Lymphomas

In brief

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.

Key facts

Study ID

NCT02675439

Run by

Chinook Therapeutics, Inc. (formerly Aduro)

People needed

47

Starts

2016-04-28

Expected to finish

2020-08-06

Last updated by the study team

2021-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Colorado School of Medicine — Aurora, Colorado, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Columbia University Medical Center-Herbert Irving Pavilion — New York, New York, United States
• University of Texas/MD Anderson Cancer Center MD Anderson PSC — Houston, Texas, United States
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.