Trial record 1 of 1 for:
NCT02675439
Safety and Efficacy of MIW815 (ADU-S100) +/- Ipilimumab in Patients With Advanced/Metastatic Solid Tumors or Lymphomas
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| ClinicalTrials.gov Identifier: NCT02675439 |
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Recruitment Status :
Recruiting
First Posted : February 5, 2016
Last Update Posted : September 26, 2018
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Sponsor:
Aduro Biotech, Inc.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Aduro Biotech, Inc.
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 75 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 |
| Study Start Date : | March 2016 |
| Estimated Primary Completion Date : | March 2020 |
| Estimated Study Completion Date : | December 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Ipilimumab
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: ADU-S100
Other Name: MIW815 |
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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
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Drug: ADU-S100
Other Name: MIW815 Biological: ipilimumab |
Primary Outcome Measures :
- 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
- Recommended dose [ Time Frame: 6 months from study start ]Using maximum tolerated dose to identify the recommended dose for future studies
Secondary Outcome Measures :
- Pharmacokinetics measured through plasma concentrations [ Time Frame: 6 months from study start ]measured through plasma concentrations
- measurement of CD8-TIL counts [ Time Frame: 6 months from study start ]
- RNA expression analysis of IFN gamma and immunomodulatory genes [ Time Frame: 6 months from study start ]
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| 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
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Must have two biopsy accessible lesions:
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* 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
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675439
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 |
Locations
| United States, Colorado | |
| University of Colorado School of Medicine | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Tara Wells 720-848-0755 Tara.Wells@ucdenver.edu | |
| Principal Investigator: Wells Messersmith, MD FACP | |
| United States, Illinois | |
| University of Chicago Medical Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Matthew Weist 773-702-1835 mweist@medicine.bsd.uchicago.edu | |
| Principal Investigator: Jason Luke, MD | |
| United States, Maryland | |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Active, not recruiting |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Amanda Stroiney 617-724-4000 Amanda_Stroiney@dfci.harvard.edu | |
| Principal Investigator: Frank Hodi, MD | |
| United States, New York | |
| Columbia University Medical Center-Herbert Irving Pavilion | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Alex Liu 212-304-5571 awl2132@cumc.columbia.edu | |
| Principal Investigator: Matthew Ingham, MD | |
| United States, Texas | |
| University of Texas/MD Anderson Cancer Center MD Anderson PSC | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Krystle Luna 713-563-2690 KALuna@mdanderson.org | |
| Principal Investigator: Funda Meric-Bernstam, MD | |
| United States, Utah | |
| University of Utah Huntsman Cancer Institute | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Cherie Peterson 801-587-5598 cherie.peterson@hci.utah.edu | |
| Principal Investigator: Wallace Akerley, MD | |
Sponsors and Collaborators
Aduro Biotech, Inc.
Novartis Pharmaceuticals
| Responsible Party: | Aduro Biotech, Inc. |
| ClinicalTrials.gov Identifier: | NCT02675439 History of Changes |
| Other Study ID Numbers: |
ADU-CL-07 |
| First Posted: | February 5, 2016 Key Record Dates |
| Last Update Posted: | September 26, 2018 |
| Last Verified: | September 2018 |
Additional relevant MeSH terms:
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |