Study of the Safety and Efficacy of MIW815 With PDR001 to 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

ClinicalTrials.gov Identifier: NCT03172936

Novartis Reference Number: CMIW815X2102J

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics and antitumor activity of MIW815 (ADU-S100) in combination with PDR001.

Condition 
Solid Tumors and Lymphomas
Phase 
Phase 1
Overall status 
Active, not recruiting
Enrollment count 
106 participants
Start date 
Sep 08, 2017
Completion date 
Sep 30, 2020
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
MIW815
MIW 815 (ADU-S100) is a STING agonist
Biological
PDR001
PDR001 is an anti-PD-1 antibody

Eligibility Criteria

Inclusion Criteria:

ECOG ≤ 1 Willing to undergo tumor biopsies from injected and distal lesions

Must have two biopsy accessible lesions:

Exclusion Criteria:

Symptomatic or untreated leptomeningeal disease. Presence of symptomatic central nervous system 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 infection. Active Epstein-Barr virus, hepatitis B virus or hepatitis C virus Malignant disease, other than that being treated in this study

Study Locations

United States
The Angeles Clinic and Research Institute
-
Los Angeles, 90025
California
United States
Novartis Investigative Site
-
Chicago, 60637
Illinois
United States
MD Anderson Cancer Center
-
Houston, 77030
Texas
United States
Seattle Cancer Care Alliance
-
Seattle, 98105
Washington
United States
Australia
Novartis Investigative Site
-
North Sydney, 2060
New South Wales
Australia
Novartis Investigative Site
-
Melbourne, 3000
Victoria
Australia
Canada
Novartis Investigative Site
-
Toronto, M5G 2M9
Ontario
Canada
Germany
Novartis Investigative Site
-
Essen, 45147
-
Germany
Japan
Novartis Investigative Site
-
Chuo ku, 104 0045
Tokyo
Japan
Netherlands
Novartis Investigative Site
-
Amsterdam, 1066 CX
-
Netherlands
Spain
Novartis Investigative Site
-
Hospitalet de LLobregat, 08907
Catalunya
Spain
Switzerland
Novartis Investigative Site
-
Zuerich, 8091
-
Switzerland

Have a question?

Call 1-999-669-6682 or email [email protected]