Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
Advanced/Metastatic Solid Tumors or Lymphomas
About this trial
This is an interventional treatment trial for Advanced/Metastatic Solid Tumors or Lymphomas
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.
Sites / Locations
- University of Colorado School of Medicine
- University of Chicago Medical Center
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
- Dana-Farber Cancer Institute
- Columbia University Medical Center-Herbert Irving Pavilion
- University of Texas/MD Anderson Cancer Center MD Anderson PSC
- University of Utah Huntsman Cancer Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dose escalation monotherapy
Dose escalation combination
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
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