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

This study is currently recruiting participants.
Verified July 2017 by Aduro Biotech, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02675439
First Posted: February 5, 2016
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Aduro Biotech, Inc.
February 2, 2016
February 5, 2016
July 11, 2017
March 2016
March 2020   (Final data collection date for primary outcome measure)
  • Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities [ Time Frame: 6 months from study start ]
    Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
  • Recommended dose [ Time Frame: 6 months from study start ]
    Using maximum tolerated dose to identify the recommended dose for future studies
Same as current
Complete list of historical versions of study NCT02675439 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics measured through plasma concentrations [ Time Frame: 6 months from study start ]
    measured through plasma concentrations
  • measurement of CD8-TIL counts [ Time Frame: 6 months from study start ]
  • RNA expression analysis of IFN gamma and immunomodulatory genes [ Time Frame: 6 months from study start ]
Same as current
Not Provided
Not Provided
 
Study of the Safety and Efficacy of MIW815 (ADU-S100) in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
A Phase I, Open Label, Multicenter Study of the Safety and Efficacy of MIW815 (ADU-S100) Administered by Intratumoral Injection to Patients With Advanced/Metastatic Solid Tumors or Lymphomas
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) administered via intratumoral injection.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced/Metastatic Solid Tumors or Lymphomas
Drug: ADU-S100
Other Name: MIW815
Experimental: Dose escalation
ADU-S100 administered intratumorally on Days 1, 8 and 15 of each 28-day cycle until unacceptable toxicity, progressive disease and/or treatment is discontinued; starting dose 50 micrograms
Intervention: Drug: ADU-S100
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Not Provided
March 2020   (Final data collection date for primary outcome measure)

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), HBV (hepatitis B virus) or HCV (hepatitis C virus)
  • Malignant disease, other than that being treated in this study.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
United States
 
 
NCT02675439
ADU-CL-07
Not Provided
Not Provided
Not Provided
Aduro Biotech, Inc.
Aduro Biotech, Inc.
Novartis Pharmaceuticals
Not Provided
Aduro Biotech, Inc.
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP