Study 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

Additional Study Details

Phase
Phase 1
Product
  • ASP8374
  • Pembrolizumab
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    169
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants 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? Contact us by filling out your information to the right and we’ll respond to you.

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    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
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    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
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    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

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      Locations

      Contact Us
      Contact Us
      Withdrawn
      Site IT39013
      Pisa, Italy
      Completed
      Honor Health Research Institute
      Scottsdale, AZ, United States, 85258
      Completed
      Site IT39009
      Milano, Italy
      Completed
      Site GB44006
      London, United Kingdom
      Completed
      Site CA15004
      Edmonton, Alberta, Canada, T6G 1Z2
      Completed
      Mary Crowley Research Center
      Dallas, TX, United States, 75251
      Completed
      Fox Chase Cancer Center
      Philadelphia, PA, United States, 19111
      Completed
      Site KR82001
      Seoul, Republic of Korea, 03080
      Completed
      University of Pittsburgh Cancer Institute
      Pittsburgh, PA, United States, 15232
      Withdrawn
      Site GB44001
      Leeds, United Kingdom
      Completed
      Site TW88603
      Taipei City, Taiwan, Province of China
      Completed
      Site IT39010
      Modena, Italy
      Completed
      Site TW88602
      Taichung, Taiwan, Province of China, 00404
      Withdrawn
      Site IT39007
      Siena, Italy
      Completed
      Site CA15002
      Montreal, Quebec, Canada, H3T 1E2
      Completed
      Site IT39008
      Milano, Italy
      Completed
      Huntsman Cancer Institute
      Salt Lake City, UT, United States, 84112
      Completed
      Site PT35106
      Porto, Portugal
      Completed
      Site ES34009
      Barcelona, Spain
      Completed
      Henry Ford Health System
      Detroit, MI, United States, 48202
      Completed
      Site ES34001
      Madrid, Spain
      Completed
      University of California, San Francisco
      San Francisco, CA, United States, 94115
      Completed
      Site GB44004
      Newcastle upon Tyne, United Kingdom
      Withdrawn
      Site IT39012
      Meldola, Italy
      Completed
      Site GB44005
      Sutton Surry, United Kingdom
      Withdrawn
      Icahn School of Medicine at Mount Sinai
      New York, NY, United States, 10029
      Completed
      Site IT39004
      Ancona, Italy
      Completed
      University of Kansas Cancer Center
      Fairway, KS, United States, 66205
      Completed
      Virginia Cancer Specialists
      Fairfax, VA, United States, 22031
      Completed
      Site GB44003
      London, United Kingdom
      Completed
      Mount Sinai Comprehensive Cancer Center
      Miami Beach, FL, United States, 33140
      Completed
      Site CA15001
      Toronto, ON, Canada, M5G 2M9
      Completed
      Site KR82005
      Seongnam-Si, Gyeonggi-do, Republic of Korea, 013620
      Completed
      SIte KR82002
      Seoul, Republic of Korea, 120-752
      Completed
      Site KR82004
      Goyang-si, Gyeonggi-do, Republic of Korea, 410-769
      Completed
      Site ES34006
      Madrid, Spain
      Completed
      Cedars-Sinai Medical Center
      Los Angeles, CA, United States, 90048
      Completed
      Medical College of Wisconsin
      Milwaukee, WI, United States, 53226-3522
      Completed
      University Hospital of Cleveland
      Cleveland, Ohio, United States, 44106
      Completed
      Site IT39011
      Negrar, Italy
      Completed
      Site ES34002
      Barcelona, Spain
      Completed
      Columbia University Medical Center
      New York, NY, United States, 10032
      Completed
      Site KR82006
      Seoul, Republic of Korea
      Completed
      Site ES34010
      Barcelona, Spain
      Completed
      Site JP81001
      Chuo-ku, Japan
      Completed
      Site ES34013
      Madrid, Spain
      Completed
      University of Iowa Hospitals and Clinics
      Iowa City, IA, United States, 52242
      Withdrawn
      University of Arizona
      Tucson, Arizona, United States, 85719
      Completed
      University of California, Davis
      Sacramento, CA, United States, 95817
      Completed
      Site ES34003
      Barcelona, Spain
      Completed
      Site ES34014
      Valencia, Spain
      Completed
      Site IT39003
      Milano, Italy
      Completed
      Site PT35101
      Lisboa, Portugal
      Completed
      Sarah Cannon Research Institute
      Nashville, TN, United States, 37203
      Completed
      Karmanos Cancer Institute
      Detroit, MI, United States, 48201
      Completed
      Site IT39005
      Monza, Italy
      Completed
      Site CA15003
      Toronto, ON, Canada, M4N 3M5
      Completed
      University of California Los Angeles
      Los Angeles, CA, United States, 90095
      Withdrawn
      University of North Carolina
      Chapel Hill, NC, United States, 27599
      Completed
      Site TW88601
      Tainan, Taiwan, Province of China
      Completed
      Site IT39002
      Milano, Italy

      Frequently Asked Questions

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      Should I be worried about getting a placebo?

      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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