Spots Global Cancer Trial Database for A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors
Official Title: A Phase 1b Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors
Study ID: NCT03565445
Conditions
Study Description
Brief Summary: The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab. This study will also evaluate the antitumor effect of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab.
Detailed Description: This is a dose-escalation and expansion study of ASP1948 as a single agent and in combination with nivolumab or pembrolizumab. 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 escalation cohorts will evaluate escalating dose levels of ASP1948 in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. 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. 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), metastatic castration-resistant prostate cancer (mCRPC), ovarian cancer, pancreatic cancer and breast cancer, as well as any tumor types that respond to study drug treatment during dose escalation.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Yale Center for Clinical Investigation, New Haven, Connecticut, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Cancer Center at Greater Baltimore Medical, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Washington University, Saint Louis, Missouri, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
UPMC- Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
University of South Carolina, Charleston, South Carolina, United States
Sarah Cannon Research Institute - SCRI, Nashville, Tennessee, United States
Henry-Joyce Cancer Center, Nashville, Tennessee, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
Virginia Cancer Care Specialist, PC, Fairfax, Virginia, United States
University of Washington-Seattle Cancer Care Alliance, Seattle, Washington, United States
Site CA15002, Edmonton, , Canada
Site CA15004, Montreal, , Canada
Site IT39008, Milano, , Italy
Site IT39006, Modena, , Italy
Site JP81002, Chiba, , Japan
Site JP81001, Tokyo, , Japan
Site KR82001, Seoul, , Korea, Republic of
Site KR82002, Seoul, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82004, Seoul, , Korea, Republic of
Site KR82005, Seoul, , Korea, Republic of
Site KR82006, Seoul, , Korea, Republic of
Site KR82007, Seoul, , Korea, Republic of
Site PT35104, Porto, , Portugal
Site ES34002, Barcelona, , Spain
Site ES34006, Barcelona, , Spain
Site ES34010, Barcelona, , Spain
Site ES34014, Barcelona, , Spain
Site ES34003, Cataluna, , Spain
Site ES34004, Cataluna, , Spain
Site ES34007, Madrid, , Spain
Site ES34012, Madrid, , Spain
Site TW88601, Taipei, , Taiwan
Site TW88602, Taipei, , Taiwan
Site GB44006, Manchester, , United Kingdom
Contact Details
Name: Medical Monitor
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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