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

Primary Purpose

Advanced/Metastatic Solid Tumors or Lymphomas

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ADU-S100
ipilimumab
Sponsored by
Chinook Therapeutics, Inc. (formerly Aduro)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced/Metastatic Solid Tumors or Lymphomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

Dose escalation monotherapy

Dose escalation combination

Arm Description

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

Outcomes

Primary Outcome Measures

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
Recommended dose
Using maximum tolerated dose to identify the recommended dose for future studies

Secondary Outcome Measures

Pharmacokinetics measured through plasma concentrations
measured through plasma concentrations
measurement of CD8-TIL counts
RNA expression analysis of IFN gamma and immunomodulatory genes

Full Information

First Posted
February 2, 2016
Last Updated
December 10, 2021
Sponsor
Chinook Therapeutics, Inc. (formerly Aduro)
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02675439
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
No substantial anti-tumor activity was observed.
Study Start Date
April 28, 2016 (Actual)
Primary Completion Date
December 11, 2019 (Actual)
Study Completion Date
August 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinook Therapeutics, Inc. (formerly Aduro)
Collaborators
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced/Metastatic Solid Tumors or Lymphomas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose escalation monotherapy
Arm Type
Experimental
Arm Description
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
Arm Title
Dose escalation combination
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ADU-S100
Other Intervention Name(s)
MIW815
Intervention Type
Biological
Intervention Name(s)
ipilimumab
Primary Outcome Measure Information:
Title
Safety: Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
Description
Number of patients reporting treatment-related adverse events that qualify as dose-limiting toxicities
Time Frame
6 months from study start
Title
Recommended dose
Description
Using maximum tolerated dose to identify the recommended dose for future studies
Time Frame
6 months from study start
Secondary Outcome Measure Information:
Title
Pharmacokinetics measured through plasma concentrations
Description
measured through plasma concentrations
Time Frame
6 months from study start
Title
measurement of CD8-TIL counts
Time Frame
6 months from study start
Title
RNA expression analysis of IFN gamma and immunomodulatory genes
Time Frame
6 months from study start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Columbia University Medical Center-Herbert Irving Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center MD Anderson PSC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Utah Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32823563
Citation
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.
Results Reference
derived

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

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