Description:
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.
Title
- Brief Title: Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
- 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
Clinical Trial IDs
- ORG STUDY ID:
ADU-CL-07
- NCT ID:
NCT02675439
Conditions
- Advanced/Metastatic Solid Tumors or Lymphomas
Interventions
Drug | Synonyms | Arms |
---|
ADU-S100 | MIW815 | Dose escalation combination |
ipilimumab | | Dose escalation combination |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose escalation monotherapy | Experimental | 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 | |
Dose escalation combination | Experimental | 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 | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities |
Time Frame: | 6 months from study start |
Safety Issue: | |
Description: | Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities |
Secondary Outcome Measures
Measure: | Pharmacokinetics measured through plasma concentrations |
Time Frame: | 6 months from study start |
Safety Issue: | |
Description: | measured through plasma concentrations |
Measure: | measurement of CD8-TIL counts |
Time Frame: | 6 months from study start |
Safety Issue: | |
Description: | |
Measure: | RNA expression analysis of IFN gamma and immunomodulatory genes |
Time Frame: | 6 months from study start |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Aduro Biotech, Inc. |
Last Updated
July 9, 2020