Study summary

The main aims of this study are:

• To check the safety of ASP1002 in people with certain solid tumors.

• To check if the people can tolerate ASP1002.

• To find a suitable dose of ASP1002.

This study will be in 2 parts.

In Part 1, different small groups of people will receive lower to higher doses of ASP1002. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP1002 to use in Part 2 of the study.

In Part 2, other different small groups of people will receive doses of ASP1002 that worked the best in Part 1.

People in this study will be adults with metastatic or locally advanced solid tumors with high levels of a protein called claudin 4. The people’s cancer will have either spread to other parts of the body (metastatic) or spread to tissue close by (locally advanced).

They will have been previously treated with available standard therapies or refused to receive those treatments.

In both parts of the study, ASP1002 (the study treatment) will be given to people slowly through a tube into a vein. This is called an infusion. This will happen every week, every other week, or every 3 weeks, in treatment cycles. Treatment cycles may be 21 days or 28 days long. People in this study will continue treatment for up to 2 years until: they have medical problems that prevent them from continuing treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; they do not come back for treatment.

During the study, people will visit the clinic several times for a health check. This includes standard safety checks and reporting any medical problems. Every few weeks, the study doctors will check if each person’s cancer has stayed the same or got worse. This will be done by scans (CT or MRI scans). Tumor samples will be taken during the study and people will have the option of giving a tumor sample after treatment has finished.

People will visit the clinic within 7 days after stopping treatment for a health check. Then, they may visit the clinic at 1 month and 3 months after stopping treatment for further health checks. People will have follow-up health checks for up to 1 year after their last dose of ASP1002.

Additional Study Details

Phase
Phase 1
Product
  • ASP1002
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    210
    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 ASP1002 in adults for treatment of 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 Virginia
      Fairfax, Virginia, United States, 22031
      Recruiting
      Prisma Health-Upstate Cancer Institute
      Greenville, South Carolina, United States, 29605
      Completed
      SCRI Oncology Partners
      Nashville, Tennessee, United States, 37203
      Recruiting
      Mary Crowley Cancer Research Center
      Dallas, Texas, United States, 75251
      Recruiting
      University of Florida
      Gainesville, FL, United States, 32610
      Recruiting
      University of Iowa Hospitals
      Iowa City, IA, United States, 52242
      Recruiting
      Norton Cancer Institute
      Louisville, KY, United States, 40202
      Recruiting
      University Hospitals of Cleveland
      Cleveland, OH, United States, 44106
      Active, not recruiting
      University of Texas Southwestern
      Dallas, TX, United States, 75235
      Recruiting
      Yale University Cancer Center
      New Haven, CT, United States, 06520
      Recruiting
      HealthPartners Cancer Research Center
      St. Paul, Minnesota, United States, 55101
      Recruiting
      Henry Ford Hospital
      Detroit, Michigan, United States, 48202
      Recruiting
      Icahn School of Medicine at Mount Sinai
      New York, New York, United States, 10029
      Recruiting
      Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
      Plainville, CT, United States, 06062
      Recruiting
      Swedish Cancer Institute
      Edmonds, Washington, United States, 21632

      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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