Spots Global Cancer Trial Database for A Study of ASP1951 in Subjects With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of ASP1951 in Subjects With Advanced Solid Tumors
Official Title: A Phase 1b Study of ASP1951, a GITR Agonistic Antibody, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Study ID: NCT03799003
Conditions
Study Description
Brief Summary: The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.
Detailed Description: This is a dose-escalation and expansion study of ASP1951. The study consists of 3 periods for monotherapy and combination therapy: screening, treatment and follow up, followed by an optional Re-treatment period for participants that qualify. The monotherapy escalation cohorts will evaluate escalating dose levels of ASP1951 in participants with locally advanced (unresectable) or metastatic solid tumor malignancies including but not limited to squamous cell carcinoma of the head and neck (SCCHN), colorectal cancer, metastatic castration-resistant prostate cancer (mCRPC) and cervical cancer. The combination escalation cohorts will evaluate escalating dose levels of ASP1951 in combination with a fixed dose of pembrolizumab. For dose expansion, the tumor-specific cohorts will include participants with squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC) (all PD-L1 status), NSCLC PDL1 high, and cervical cancer, as well as participants with any tumor types that respond to study drug treatment during dose escalation. Participants may reinitiate study drug treatment in the optional Re-treatment period after confirmation that the participant meets all the re-treatment eligibility criteria. After discontinuation of study drug, all participants will complete an end-of-treatment visit, along with 30-day and 90 day safety follow-up visits from the last dose of study drug.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Clinical Research Cent, Tucson, Arizona, United States
University of California, Sacramento, California, United States
University of Florida, Davis C, Gainesville, Florida, United States
Emory University, Atlanta, Georgia, United States
Augusta University, Augusta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Iowa Hospitals, Iowa City, Iowa, United States
Henry Ford Health System, Detroit, Michigan, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Comprehensive Cancer Nevada, Las Vegas, Nevada, United States
Rutgers Cancer Institute, New Brunswick, New Jersey, United States
Icahn school of Medicine at Mount Sinai, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Hollings Cancer Center, Charleston, South Carolina, United States
South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Multicare Regional Cancer Center Tacoma, Tacoma, Washington, United States
Site CA15002, Montreal, , Canada
Site CA15005, Montreal, , Canada
Site CA15004, Ontario, , Canada
Site KR82002, Chungcheongbukdo, , Korea, Republic of
Site KR82005, Daegu, , Korea, Republic of
Site KR82001, Gyeonggi-do, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82004, Seoul, , Korea, Republic of
Site KR82006, Seoul, , Korea, Republic of
Site KR82007, Seoul, , Korea, Republic of
Site TW88603, Taichung, , Taiwan
Site TW88604, Taipei, , Taiwan
Contact Details
Name: Medical Monitor
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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