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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Vice President Medical Sciences - Oncology

Affiliation: Astellas Pharma Global Development, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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