Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
NCT ID: NCT02675439
Last Updated: 2021-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
47 participants
INTERVENTIONAL
2016-04-28
2020-08-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
ADU-S100
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
ADU-S100
ipilimumab
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ADU-S100
ipilimumab
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Chinook Therapeutics, Inc. (formerly Aduro)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado School of Medicine
Aurora, Colorado, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Columbia University Medical Center-Herbert Irving Pavilion
New York, New York, United States
University of Texas/MD Anderson Cancer Center MD Anderson PSC
Houston, Texas, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ADU-CL-07
Identifier Type: -
Identifier Source: org_study_id