Spots Global Cancer Trial Database for A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors
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Trial Identification
Brief Title: A Study of an Intratumoral Oncolytic Virus in Patients With Advanced Metastatic Solid Tumors
Official Title: A Phase 1, Open-label Study of ASP9801, an Oncolytic Virus, Administered by Intratumoral Injection as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced/Metastatic Solid Tumors
Study ID: NCT03954067
Study Description
Brief Summary: The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801 as a single agent, as well as in combination with pembrolizumab, an anti-programmed cell death protein 1 (PD-1) checkpoint inhibitor.
Detailed Description: The study consists of two parts: dose escalation and recommended phase 2 dose expansion. Each part of the study will include two separate groups of participants. Group A will include participants who will have cutaneous/subcutaneous tumors injected, and group B will include participants who will have visceral tumors injected. In dose escalation part only ASP9801 will be assessed. In dose expansion part along with ASP9801 (monotherapy) ASP9801 + Pembrolizumab (combination therapy) will be assessed. The study will consist of the following periods: screening, initial treatment period (two 28 day cycles), optional extended treatment period (continued 28 day cycles) and a follow up period (safety and survival follow up).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Arizona - Arizona Cancer Center, Tucson, Arizona, United States
The Angeles Clinic and Research Institute, Los Angeles, California, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Henry Ford Hospital, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Roswell Park Cancer Institute - Medical Oncology, Buffalo, New York, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
UVA Cancer Center, Charlottesville, Virginia, United States
VCU Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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