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Trial record 1 of 1 for:    NCT02675439
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Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675439
Recruitment Status : Active, not recruiting
First Posted : February 5, 2016
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Aduro Biotech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Solid Tumors or Lymphomas Drug: ADU-S100 Biological: ipilimumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 28, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: Dose escalation monotherapy
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
Drug: ADU-S100
Other Name: MIW815

Experimental: Dose escalation combination
ADU-S100 administered intratumorally on Days 1 and 8 of each 21-day cycle (starting dose 200 micrograms) and ipilimumab, i.v., (3 mg/kg) on day 1 of each 21-day cycle for the first 4 cycles. Dosing is continued until unacceptable toxicity, progressive disease and/or treatment is discontinued
Drug: ADU-S100
Other Name: MIW815

Biological: ipilimumab



Primary Outcome Measures :
  1. 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

  2. Recommended dose [ Time Frame: 6 months from study start ]
    Using maximum tolerated dose to identify the recommended dose for future studies


Secondary Outcome Measures :
  1. Pharmacokinetics measured through plasma concentrations [ Time Frame: 6 months from study start ]
    measured through plasma concentrations

  2. measurement of CD8-TIL counts [ Time Frame: 6 months from study start ]
  3. RNA expression analysis of IFN gamma and immunomodulatory genes [ Time Frame: 6 months from study start ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675439


Locations
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United States, Colorado
University of Colorado School of Medicine
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Columbia University Medical Center-Herbert Irving Pavilion
New York, New York, United States, 10032
United States, Texas
University of Texas/MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, United States, 77030-4009
United States, Utah
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Aduro Biotech, Inc.
Novartis Pharmaceuticals

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Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT02675439    
Other Study ID Numbers: ADU-CL-07
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents