Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas

  • Interventional
  • Not Recruiting
  • NCT02675439
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years and up

Accepting 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.
  • Solid Tumors
  • Cancer

At a Glance

National Government IDNCT02675439

IRB#IRB15-1807

Lead SponsorAduro Biotech, Inc.

Lead PhysicianRandy Sweis

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting