Study summary

This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D.

This study will be in 2 parts.

In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2.

In Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments.

Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can’t tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.

Additional Study Details

Phase
Phase 1
Product
  • ASP3082
  • Cetuximab
  • Leucovorin
  • Oxaplatin
  • Fluorouracil
  • Irinotecan
  • Nanoparticle albumin-bound-paclitaxel
  • Gemcitabine
  • Docetaxel
  • Pembrolizumab
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    651
    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 ASP3082 in adults with advanced 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
      NEXT Oncology
      San Antonio, Texas, United States, 78229
      Recruiting
      SCRI Oncology Partners
      Nashville, Tennessee, United States, 37203
      Recruiting
      Columbia University - Herbert Irving Comprehensive Cancer Center
      New York, New York, United States, 10032
      Recruiting
      Florida Cancer Specialists & Research Institute Sarasota
      Sarasota, Florida, United States, 34232-6422
      Recruiting
      NEXT Oncology - Virginia Cancer Specialists
      Fairfax, Virginia, United States, 22031
      Recruiting
      Memorial Sloan Kettering Cancer Center
      New York, New York, United States, 10065
      Recruiting
      UCLA Santa Monica Hematology Oncology
      Santa Monica, California, United States, 90404
      Recruiting
      University of Kansas Medical Center
      Westwood, Kansas, United States, 66205
      Recruiting
      Vanderbilt University Medical Center
      Nashville, Tennessee, United States, 37232
      Recruiting
      Smilow Cancer Center at Yale New Haven Hospital
      New Haven, Connecticut, United States, 06520-8028
      Recruiting
      Washington University School of Medicine
      St. Louis, Missouri, United States, 63110
      Recruiting
      Dana Farber Cancer Institute
      Boston, MA, United States, 02215
      Recruiting
      Cancer Institute Hospital of JFCR
      Koto-ku, Tokyo, Japan
      Recruiting
      National Cancer Center Hospital
      Chuo-ku, Tokyo, Japan
      Recruiting
      National Cancer Center Hospital East
      Kashiwa, Chiba, Japan
      Recruiting
      Roswell Park Cancer Institute
      Buffalo, NY, United States, 14263
      Recruiting
      Kindai University Hospital
      Osakasayama, Osaka, Japan
      Recruiting
      Shizuoka Cancer Center
      Sunto-gun, Shizuoka, Japan
      Recruiting
      Site FR33004
      Villejuif, Île-de-France, France
      Recruiting
      Kanagawa Cancer Center
      Yokohama, Kanagawa, Japan
      Recruiting
      Shikoku Cancer Center
      Matsuyama, Ehime, Japan
      Recruiting
      Osaka International Cancer Institute
      Osaka, Osaka, Japan
      Recruiting
      Site FR33003
      La Tronche, Grenobele, France
      Recruiting
      Site FR33001
      Lyon, France
      Recruiting
      Site ES34003
      Sevilla, Sevilla, Spain
      Recruiting
      Site ES34004
      Madrid, Madrid, Spain
      Recruiting
      Site KR82002
      Seongnam-si, Gyeonggi-do, Republic of Korea
      Recruiting
      Site KR82003
      Seodaemun-gu, Seoul, Republic of Korea
      Recruiting
      Site KR82001
      Jongno -Gu, Seoul, Republic of Korea
      Recruiting
      Site KR82004
      Songpa-gu, Seoul, Republic of Korea
      Recruiting
      Site FR33002
      Bordeaux, France
      Recruiting
      Aichi Cancer Center
      Nagoya, Aichi, Japan
      Recruiting
      City of Hope National Medical Center
      Duarte, CA, United States, 91010
      Recruiting
      Site FR33005
      Lyon, France
      Recruiting
      Site ES34002
      Málaga, Spain
      Recruiting
      Site ES34001
      Barcelona, Spain
      Recruiting
      Case Western
      Cleveland, Ohio, United States, 44106
      Recruiting
      University of Wisconsin Hospital
      Madison, Wisconsin, United States, 53792
      Recruiting
      Florida Cancer Specialist
      Lake Mary, Florida, United States, 32746
      Recruiting
      Denver HealthONE Drug Development Unit
      Denver, Colorado, United States, 80218
      Recruiting
      Hokkaido University Hospital
      Sapporo, Hokkaido, Japan
      Recruiting
      Yamaguchi University Hospital
      Ube, Yamaguchi, Japan
      Recruiting
      Tohoku University Hospital
      Sendai, Miyagi, Japan
      Recruiting
      Oregon Health and Science University
      Portland, OREGON, United States, 97239
      Recruiting
      Beijing Cancer Hospital
      Beijing, Beijing, China
      Recruiting
      Fudan University Shanghai Cancer Center
      Xuhui District, Shanghai, China
      Recruiting
      Georgetown University Hospital
      Washington, DC, United States, 20007

      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?