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

• ClinicalTrials.gov Identifier: NCT02675439
• Recruitment Status: Active, not recruiting
• First Posted: February 5, 2016
• Last Update Posted: January 13, 2020
• Sponsor: Aduro Biotech, Inc.
• Collaborator: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Aduro Biotech, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Advanced/Metastatic Solid Tumors or Lymphomas	Drug: ADU-S100; Biological: ipilimumab	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 28, 2016
• Estimated Primary Completion Date: March 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

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 Name: 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 Name: MIW815; Biological: ipilimumab

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Pharmacokinetics measured through plasma concentrations [ Time Frame: 6 months from study start ]
   measured through plasma concentrations
2. measurement of CD8-TIL counts [ Time Frame: 6 months from study start ]
3. RNA expression analysis of IFN gamma and immunomodulatory genes [ Time Frame: 6 months from study start ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Colorado

University of Colorado School of Medicine

Aurora, Colorado, United States, 80045

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

United States, Maryland

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, New York

Columbia University Medical Center-Herbert Irving Pavilion

New York, New York, United States, 10032

United States, Texas

University of Texas/MD Anderson Cancer Center MD Anderson PSC

Houston, Texas, United States, 77030-4009

United States, Utah

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Aduro Biotech, Inc.

Novartis Pharmaceuticals

More Information

• Responsible Party: Aduro Biotech, Inc.
• ClinicalTrials.gov Identifier: NCT02675439
• Other Study ID Numbers: ADU-CL-07
• First Posted: February 5, 2016
• Last Update Posted: January 13, 2020
• Last Verified: January 2020

Additional relevant MeSH terms:

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Ipilimumab; Antineoplastic Agents, Immunological; Antineoplastic Agents