Advanced/Metastatic Solid Tumors or Lymphomas Clinical Trial
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
| Verified date | December 2021 |
| Source | Chinook Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 47 |
| Est. completion date | August 6, 2020 |
| Est. primary completion date | December 11, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Colorado School of Medicine | Aurora | Colorado |
| United States | Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | University of Texas/MD Anderson Cancer Center MD Anderson PSC | Houston | Texas |
| United States | Columbia University Medical Center-Herbert Irving Pavilion | New York | New York |
| United States | University of Utah Huntsman Cancer Institute | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Chinook Therapeutics, Inc. (formerly Aduro) | Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities | Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities | 6 months from study start | |
| Primary | Recommended dose | Using maximum tolerated dose to identify the recommended dose for future studies | 6 months from study start | |
| Secondary | Pharmacokinetics measured through plasma concentrations | measured through plasma concentrations | 6 months from study start | |
| Secondary | measurement of CD8-TIL counts | 6 months from study start | ||
| Secondary | RNA expression analysis of IFN gamma and immunomodulatory genes | 6 months from study start |