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Brief Title: A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Official Title: A Phase 1b Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Study ID: NCT03260322
Brief Summary: The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab. The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate \[ORR\], duration of response \[DOR\], persistence of response after discontinuation, and disease control rate \[DCR\]) of ASP8374 when administered as a single agent and in combination with pembrolizumab. NTP: Neutropenia NHAE:Non-haematological AE GBS: Guillain-Barré syndrome"" IRR: Infusion-related reaction AST: Aspartate aminotransferase ALT: Alanine aminotransferase MS/MG: Myasthenia Syndrome/Myasthenia Gravis TRT: Treatment-related Toxicity TCP: Thrombocytopenia
Detailed Description: This is a multi-center, multiple-dose, dose-escalation and expansion study of ASP8374 as a single agent and in combination with pembrolizumab. After discontinuation of study drug treatment (initial treatment and re-treatment), 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 ASP8374. Participants will be enrolled in respectively escalation cohorts or expansion cohorts. The 90-day safety follow-up visit is optional for participants who discontinue due to progressive disease or initiate new anticancer treatment after the last dose of study drug. Escalation cohorts: Approximately 60 participants may be enrolled in the escalation cohorts (approximately 30 participants for monotherapy and 30 participants for combination therapy). Expansion cohorts: The total number of subjects in the expansion cohorts will depend on the observed pharmacokinetic and antitumor activity. It is estimated that approximately 240 participants may be enrolled in the monotherapy and combination therapy expansion cohorts. As the number of participants in the escalation cohorts and the expansion cohorts will depend on the observed Dose Limiting Toxicity (DLT), pharmacokinetics and antitumor activity, approximately 300 participants are expected to be enrolled.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Honor Health Research Institute, Scottsdale, Arizona, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
University of California Los Angeles, Los Angeles, California, United States
University of California, Davis, Sacramento, California, United States
University of California, San Francisco, San Francisco, California, United States
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Kansas Cancer Center, Fairway, Kansas, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Columbia University Medical Center, New York, New York, United States
University Hospital of Cleveland, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Mary Crowley Research Center, Dallas, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Site CA15004, Edmonton, Alberta, Canada
Site CA15003, Toronto, Ontario, Canada
Site CA15001, Toronto, Ontario, Canada
Site CA15002, Montreal, Quebec, Canada
Site IT39004, Ancona, , Italy
Site IT39002, Milano, , Italy
Site IT39003, Milano, , Italy
Site IT39008, Milano, , Italy
Site IT39009, Milano, , Italy
Site IT39010, Modena, , Italy
Site IT39005, Monza, , Italy
Site IT39011, Negrar, , Italy
Site JP81001, Chuo-ku, , Japan
Site KR82004, Goyang-si, Gyeonggi-do, Korea, Republic of
Site KR82005, Seongnam-Si, Gyeonggi-do, Korea, Republic of
Site KR82001, Seoul, , Korea, Republic of
SIte KR82002, Seoul, , Korea, Republic of
Site KR82006, Seoul, , Korea, Republic of
Site PT35101, Lisboa, , Portugal
Site PT35106, Porto, , Portugal
Site ES34002, Barcelona, , Spain
Site ES34003, Barcelona, , Spain
Site ES34009, Barcelona, , Spain
Site ES34010, Barcelona, , Spain
Site ES34001, Madrid, , Spain
Site ES34006, Madrid, , Spain
Site ES34013, Madrid, , Spain
Site ES34014, Valencia, , Spain
Site TW88602, Taichung, , Taiwan
Site TW88601, Tainan, , Taiwan
Site TW88603, Taipei City, , Taiwan
Site GB44003, London, , United Kingdom
Site GB44006, London, , United Kingdom
Site GB44004, Newcastle upon Tyne, , United Kingdom
Site GB44005, Sutton Surry, , United Kingdom
Name: Vice President Medical Sciences - Oncology
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR