Clinical trial NCT02675439: Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced/Metastatic Solid Tumors or Lymphomas
Lead sponsor: Chinook Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novartis Pharmaceuticals
First posted: 2016-02-05
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
timeFrame: 6 months from study start
measure: Recommended dose
timeFrame: 6 months from study start
Secondary outcomes:
measure: Pharmacokinetics measured through plasma concentrations
timeFrame: 6 months from study start
measure: measurement of CD8-TIL counts
timeFrame: 6 months from study start
measure: RNA expression analysis of IFN gamma and immunomodulatory genes
timeFrame: 6 months from study start
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center-Herbert Irving Pavilion
state: New York
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center MD Anderson PSC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
Study officials:
References:
citation: Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.