Study summary

Immune therapies work with the body’s immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending “off” signals to T-cells. The researchers are finding ways to switch the T-cells back on.

Before a treatment can be approved for use, clinical studies need to be done. This study will provide more information on ASP1570 in adults with advanced solid tumors. ASP1570 will either be given by itself, or given with another medicine called pembrolizumab, or given with a standard cancer therapy.

The main aims of this study are:

⦁ To check the safety of ASP1570

⦁ To check how well ASP1570 is tolerated

⦁ To find a suitable dose of ASP1570

This study is for adults with advanced solid tumors. Their tumor has either grown outside of the area where it started (locally advanced and unresectable) or it has spread to other parts of the body (metastatic). Their cancer gets worse after standard therapy or they are unable to have standard therapy. The study doctors can give more advice about who can take part.

This study will be in 2 parts.

In Part 1, the most suitable dose of ASP1570 to give to people with advanced solid tumors will be worked out. Different small groups of people with advanced solid tumors will take lower to higher doses of ASP1570. People will either be given ASP1570 by itself, ASP1570 with another medicine called pembrolizumab, or ASP1570 with a standard cancer therapy. The study treatment given depends on the type of cancer people have. There are different doses of ASP1570, with each group staying on the same dose. There is just 1 dose of pembrolizumab. The dose of a standard cancer therapy depends on its label. After taking the lowest dose of ASP1570, the first group will be checked for medical problems. The next group can only take the higher dose of ASP1570 if the first group tolerates the lowest dose . This will continue in the same way for each group.

Each group will take tablets of ASP1570 either once or twice every day in a 21-day cycle. People taking part in Japan will stay in hospital for up to 21 days during the first treatment cycle only. People will continue with more treatment cycles on the same dose unless they can’t tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment. People who also receive treatment with pembrolizumab will be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). People who are receiving standard cancer therapy (with ASP1570) will be treated according to its label.

In Part 2, different small groups of people with advanced solid tumors will take the most suitable dose of ASP1570 worked out from Part 1. The dose will not go above the highest dose that people could tolerate from Part 1. Some groups of people will have specific advanced tumors. These include colorectal cancer or non-small cell lung cancer (NSCLC for short). Again, each group will take tablets of ASP1570 once or twice every day in a 21-day or 28-day cycle. People with NSCLC will also receive docetaxel, one of the standard cancer therapies. People with stable colorectal cancer (known as CRC with microsatellite stability, or MSS-CRC) will also receive another standard cancer therapy called TAS-102 with bevacizumab. The standard cancer therapies will be given according to their label. People with solid tumors will also receive pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). All groups will continue with more treatment cycles with ASP1570 by itself with pembrolizumab, or with one of the standard cancer therapies unless they can’t tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment.

Additional Study Details

Phase
Phase 1/2
Product
  • ASP1570
  • pembrolizumab
  • Trifluridine + Tipiracil
  • Bevacizumab
  • Docetaxel
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    310
    Show Additional Study Details

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    Would you like more information about clinical trial sites that are recruiting participants for A Study of ASP1570 alone or in combination with pembrolizumab or standard therapies in adults with solid tumors? Contact us by filling out your information to the right and we’ll respond to you.

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      Locations

      Contact Us
      Contact Us
      Recruiting
      Nebraska Methodist Hospital
      Omaha, Nebraska, United States, 68130
      Recruiting
      Mary Crowley Research Center
      Dallas, TX, United States, 75230
      Recruiting
      Providence Medical Foundation
      Fullerton, CA, United States, 92835
      Active, not recruiting
      SCRI Oncology Partners
      Nashville, TN, United States, 37203
      Recruiting
      Florida Cancer Specialist & Research Institute Sarasota
      Sarasota, FL, United States, 34232
      Recruiting
      University Hospitals Cleveland Medical Center
      Cleveland, OH, United States, 44106
      Recruiting
      UPMC Hillman Cancer Center
      Pittsburgh, PA, United States, 15232
      Recruiting
      University of Chicago
      Chicago, IL, United States, 60637
      Recruiting
      University of Kentucky Medical Center MCC-CRO
      Lexington, KY, United States, 40536
      Recruiting
      USC/Norris Comprehensive Cancer Center
      Los Angeles, CA, United States, 90033
      Recruiting
      Cancer Institute Hospital Of JFCR
      Koto-ku, Tokyo, Japan
      Recruiting
      National Cancer Center Hospital
      Chuo-ku, Tokyo, Japan
      Withdrawn
      Atlantic Health System/Morristown Medical Center
      Morristown, New Jersey, United States, 07960
      Recruiting
      California Research Institute
      Los Angeles, California, United States, 90027
      Recruiting
      University of Wisconsin Clinical Science Center
      Madison, Wisconsin, United States, 53792
      Recruiting
      Beijing Cancer Hospital
      Beijing, China
      Recruiting
      Shanghai East Hospital
      Shanghai, China
      Recruiting
      Site PR1601
      Río Piedras, Puerto Rico
      Recruiting
      Shizuoka Cancer Center
      Sunto-gun, Shizuoka, Japan, 411-8777
      Recruiting
      Kanagawa Cancer Center
      Yokohama, Kanagawa, Japan, 241-8515
      Recruiting
      Site ES34002
      Madrid, Spain
      Recruiting
      Site ES34005
      A Coruña, Barcelona, Spain
      Recruiting
      Site ES34006
      Pozuelo de Alarcón, Spain
      Recruiting
      Site ES34007
      Malaga, Spain
      Recruiting
      Site FR33002
      Bordeaux, France
      Recruiting
      Site ES34004
      Avda, Spain
      Recruiting
      American Oncology Partners
      Bethesda, Maryland, United States, 20817
      Recruiting
      ES34003
      Santiago De Compostela, Spain
      Recruiting
      ES34008
      Málaga, Spain
      Recruiting
      FR33001
      Poitiers, France
      Recruiting
      FR33005
      St Herblain, France
      Recruiting
      FR33007
      Besancon Cedex, France
      Recruiting
      FR33008
      Paris, France
      Recruiting
      FR33009
      Toulouse, France
      Active, not recruiting
      KR82002
      Seoul, Republic of Korea

      Frequently Asked Questions

      Are clinical trials only for people with advanced cancer?

      While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

      Will I have to stop my current treatment to participate in a clinical trial?

      Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

      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.

      Do I need a referral from my doctor to take part in a study?

      Your doctor may not know about all the opportunities for clinical trials that are available to you. Talk to your doctor or other medical provider about clinical trial information that you find. They can help you decide if a clinical trial is right for you. If you do not find any options on this website, we recommend you visit an online public registry website like clinicaltrials.gov to see a wide variety of available clinical trials.

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      What are clinical trials?

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      Why Participate in a Clinical Trial?