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.

Study Overview

• Status: Terminated
• Conditions: Advanced/Metastatic Solid Tumors or Lymphomas
• Intervention / Treatment: Drug: ADU-S100; Biological: ipilimumab

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center-Herbert Irving Pavilion
  • Texas
    • Houston, Texas, United States, 77030-4009
      • University of Texas/MD Anderson Cancer Center MD Anderson PSC
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah Huntsman Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose escalation monotherapy; 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	Drug: ADU-S100; Other Names: MIW815
Experimental: Dose escalation combination; 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	Drug: ADU-S100; Other Names: MIW815; Biological: ipilimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities	Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities	6 months from study start
Recommended dose	Using maximum tolerated dose to identify the recommended dose for future studies	6 months from study start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics measured through plasma concentrations	measured through plasma concentrations	6 months from study start
measurement of CD8-TIL counts		6 months from study start
RNA expression analysis of IFN gamma and immunomodulatory genes		6 months from study start

Collaborators and Investigators

• Sponsor: Chinook Therapeutics, Inc. (formerly Aduro)
• Collaborators: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Gogoi H, Mansouri S, Jin L. The Age of Cyclic Dinucleotide Vaccine Adjuvants. Vaccines (Basel). 2020 Aug 13;8(3):453. doi: 10.3390/vaccines8030453.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2016
• Primary Completion (Actual): December 11, 2019
• Study Completion (Actual): August 6, 2020

Study Registration Dates

• First Submitted: February 2, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab
• Other Study ID Numbers: ADU-CL-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No