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

NCT02675439 | Terminated Phase 1

• 1 other identifier: ADU-CL-07
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 7

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.

Conditions

Advanced/Metastatic Solid Tumors or Lymphomas

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pharmacokinetics 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

Study Arms (2)

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

Drug: ADU-S100

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

Drug: ADU-S100; Biological: ipilimumab

Interventions

ADU-S100 DRUG

Also known as: MIW815

Dose escalation combination; Dose escalation monotherapy

ipilimumab BIOLOGICAL

Dose escalation combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinook Therapeutics, Inc. (formerly Aduro): lead
• Novartis Pharmaceuticals: collaborator

Study Sites (7)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Columbia University Medical Center-Herbert Irving Pavilion

New York, New York, 10032, United States

Location

University of Texas/MD Anderson Cancer Center MD Anderson PSC

Houston, Texas, 77030-4009, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 32823563 DERIVED

MeSH Terms

Conditions

Lymphoma

Interventions

ADU-S100; Ipilimumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 5, 2016
• Study Start: April 28, 2016
• Primary Completion: December 11, 2019
• Study Completion: August 6, 2020
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

US (7)