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

Phase 1

Terminated

• Conditions: Advanced/Metastatic Solid Tumors or Lymphomas
• Interventions: Drug: ADU-S100; Biological: ipilimumab

• Registration Number: NCT02675439
• Lead Sponsor: Chinook Therapeutics, Inc. (formerly Aduro)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-05
• Study Start: 2016-04-28
• Primary Completion: 2019-12-11
• Study Completion: 2020-08-06
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose escalation monotherapy	ADU-S100	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	ADU-S100	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
Dose escalation combination	ipilimumab	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

University of Texas/MD Anderson Cancer Center MD Anderson PSC; 🇺🇸 Houston, Texas, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Baltimore, Maryland, United States

University of Colorado School of Medicine; 🇺🇸 Aurora, Colorado, United States

University of Utah Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

Columbia University Medical Center-Herbert Irving Pavilion; 🇺🇸 New York, New York, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States