Advanced/Metastatic Solid Tumors or Lymphomas
Conditions
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.
Interventions
DRUGADU-S100
BIOLOGICALipilimumab
Sponsors
Novartis Pharmaceuticals
Chinook Therapeutics, Inc. (formerly Aduro)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities | 6 months from study start | Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities |
| Recommended dose | 6 months from study start | Using maximum tolerated dose to identify the recommended dose for future studies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics measured through plasma concentrations | 6 months from study start | measured through plasma concentrations |
| measurement of CD8-TIL counts | 6 months from study start | — |
| RNA expression analysis of IFN gamma and immunomodulatory genes | 6 months from study start | — |
Countries
United States
Outcome results
None listed