Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in 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

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.

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.