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Astellas Study ID
AGS-22M6E-11-1

A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects with Malignant Solid Tumors that Express Nectin-4

Astellas Study ID
AGS-22M6E-11-1
Clinicaltrials.gov ID
NCT01409135
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

A study examining the safety of AGS-22M6E or ASG-22CE administered as monotherapy therapy in subjects with malignant solid tumors that express Nectin-4.

Additional Study Details

Phase
Phase 1
Product
N/A
Product
AGS-22M6E
ASG-22CE
Type
Interventional
Masking
None (Open Label)
Enrollment number
34
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Study documents

Scientific Results Summary
Available Language(s): English
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Plain Language Summary
Available Language(s): English
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Would you like more information about clinical trial sites that are recruiting participants for A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects with Malignant Solid Tumors that Express Nectin-4? Contact us by filling out your information to the right and we’ll respond to you.

  • A caregiver
  • A healthcare provider
  • A parent
  • A patient
  • 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
  • Latvia
  • Lebanon
  • Lithuania
  • Macedonia
  • Malaysia
  • Mexico
  • Montenegro
  • Morocco
  • Netherlands
  • 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

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    Completed
    UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, CA, United States, 94115
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    Completed
    University of Colorado, Denver-Aurora
    Aurora, CO, United States, 80045
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    Completed
    Emory University
    Atlanta, GA, United States, 30322
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    Completed
    Dana-Farber Cancer Institute
    Boston, MA, United States, 02115
    Contact Us
    Completed
    Karmanos Cancer institute
    Detroit, MI, United States, 48201
    Contact Us
    Completed
    Roswell Park Cancer Institute
    Buffalo, NY, United States, 14263
    Contact Us
    Completed
    Memorial Sloan Kettering Cancer Center
    New York, NY, United States, 10021
    Contact Us
    Completed
    University of North Carolina, Chapel Hill
    Chapel Hill, NC, United States, 27599
    Contact Us
    Completed
    Cross Cancer Institute
    Edmonton, Alberta, Canada, T6G 1Z2
    Contact Us
    Trial info
    Follow Trial
    Age
    18+ years
    Diamond icon
    Condition
  • Advanced/Metastatic Cancer
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Jun 2011 - Apr 2015
    Additional Study Details
    Inclusion Criteria

      (For Dose Escalation and Dose Expansion)

    • Subjects must have a tumor positive for Nectin-4 expression (as measured by central laboratory using primary or metastatic tumor tissue
    • Histologically confirmed malignant solid tumors (excluding sarcoma) that have failed all FDA approved therapies indicated for the type of metastatic cancer and line of therapy or for which they were not a candidate to receive treatment
    • Measurable disease according to RECIST criteria (version 1.1) (Eisenhauer, et. al.) defined as tumor lesions that are accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:
      • 10mm by CT scan (CT scan slice thickness no greater than 5mm
      • 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as nonmeasurable
      • 20 mm by chest X-ray
      • ≥ 15 mm in short axis for lymph nodes when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm)

      • Note: bone lesions, ascites, and pleural effusions are not considered measurable lesions

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Negative pregnancy test (women of childbearing potential)
    • Hematologic function, as follows:
      • a. Absolute neutrophil count (ANC) ≥ 1.0 x109 /L
      • b. Platelet count ≥ 100 x 109/L
      • c. Hemoglobin ≥ 8.5 g/dL
    • Renal function, as follows: serum creatinine ≤ 2.0 mg/dL, or measured 24 hour creatinine clearance of ≥ 45 mL/min
    • Total bilirubin ≤1.5 x upper limit of normal (ULN)
    • Serum albumin > 2.5 g/dL
    • Aspartate aminotransferase (AST) ≤ 1.5 x ULN
    • Alanine aminotransferase (ALT) ≤ 1.5 x ULN
    • Gamma GT ≤1.5 ULN
    • International normalized ratio (INR) < 1.5 (or ≤ 3 if on warfarin or other medications for therapeutic anticoagulation)
    • Women and men of childbearing potential must be advised and agree to practice effective methods of contraception during the course of the study

      • Inclusion Criteria for Dose Expansion Only:

      In addition to the inclusion criteria listed above, the following criteria will also be required for each expansion cohort:

      Expansion Cohort 1: Breast Cancer

    • Subjects with Histologically or cytologically diagnosed metastatic breast cancer

      • Expansion Cohort 2: Bladder Cancer

    • Histologically or cytologically confirmed bladder cancer with visceral metastases

      • Expansion Cohort 3: Lung plus other solid tumor cancer

    • Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC) or any other solid tumor cancer
    MaximizeExclusion Criteria
    • Preexisting neuropathy Grade ≥ 3 or motor neuropathy Grade ≥ 2
    • Uncontrolled brain or epidural spinal metastases
    • Use of any investigational drug within 14 days or 5 half-lives prior to first dose of study drug
    • Any anticancer therapy including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy or any other agents to treat cancer within 28 days prior to first dose of study drug
    • Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of the first dose of study drug, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by medication
    • Known HIV or AIDS
    • Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
    • History of thromboembolic events and bleeding

      • disorders ≤ 3 months (e.g.,deep vein thrombosis ( DVT) or pulmonary embolism ( PE)) prior to first dose of study drug

    • Major surgery within 28 days prior to first dose of study drug
    • Active infection requiring treatment ≤7 days prior to first dose of study drug
    • Anti-androgen therapy initiated within 28 days of enrollment (for prostate cancer patients only)
    • Positive Hepatitis B surface antigen test
    • Positive Hepatitis C antibody test

    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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