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Astellas Study ID
ASG-22CE-13-2

A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4

Astellas Study ID
ASG-22CE-13-2
Clinicaltrials.gov ID
NCT02091999
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

The purpose of this study is to evaluate the safety and pharmacokinetics of enfortumab vedotin as well as assess the immunogenicity and antitumor activity in subjects with metastatic urothelial cancer and other malignant solid tumors that express Nectin-4.

Additional Study Details

Phase
Phase 1
Product
enfortumab vedotin
Product
enfortumab vedotin
Type
Interventional
Masking
None (Open Label)
Enrollment number
213
Show Additional Study Details

Study documents

Plain Language Summary
Available Language(s): Spanish, English
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Would you like more information about clinical trial sites that are recruiting participants for A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other 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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    Active, not recruiting
    Site CA00001
    Edmonton, AB, Canada, T6G 1Z2
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    Active, not recruiting
    Site US00008
    Tampa, FL, United States, 33612
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    Active, not recruiting
    Site US00017
    Aurora, CO, United States, 80045
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    Withdrawn
    Site US00001
    Seattle, WA, United States, 98109
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    Completed
    Site CA00010
    Toronto, ON, Canada, M5G 2M9
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    Completed
    Site US00020
    Pittsburgh, PA, United States, 15232
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    Active, not recruiting
    Site US00005
    Ann Arbor, MI, United States, 48109
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    Completed
    Site US00007
    Miami, FL, United States, 33136
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    Active, not recruiting
    Site US00009
    Madison, WI, United States, 53792
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    Active, not recruiting
    Site US00019
    Stanford, CA, United States, 94305
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    Active, not recruiting
    Site CA00011
    Calgary, AB, Canada, T2N 4N2
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    Withdrawn
    Site US00014
    Baltimore, MD, United States, 21201
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    Completed
    Site US00021
    Las Vegas, NV, United States, 89119
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    Withdrawn
    Site US00025
    Spokane, WA, United States, 99208
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    Completed
    Site US00004
    Fairway, KS, United States, 66205
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    Completed
    Site US00024
    Fairfax, VA, United States, 22031
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    Withdrawn
    Site US00026
    Omaha, NE, United States, 68130
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    Completed
    Site US00013
    Philadelphia, PA, United States, 19111
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    Active, not recruiting
    Site US00006
    New Haven, CT, United States, 06520
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    Active, not recruiting
    Site US00002
    New York, NY, United States, 10065
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    Withdrawn
    Site US00022
    Dallas, TX, United States, 75251
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    Active, not recruiting
    Site US00003
    Detroit, MI, United States, 48201
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    Active, not recruiting
    Site US00023
    Chapel Hill, NC, United States, 27599
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    Completed
    Site US00018
    New York, NY, United States, 10029
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    Withdrawn
    Site US00027
    Harvey, IL, United States, 60426
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    Completed
    Site US00015
    Milwaukee, WI, United States, 53226
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    Withdrawn
    Site US00016
    Indianapolis, IN, United States, 46202
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    Active, not recruiting
    Site US00012
    Los Angeles, CA, United States, 90033
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    Trial info
    Follow Trial
    Age
    18+ years
    Diamond icon
    Condition
  • Bladder Cancer
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Jun 2014 - Dec 2021
    Additional Study Details
    Inclusion Criteria
    • Dose Escalation, Renal insufficiency and CPI-Treated Expansion cohorts: Histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.
    • Ovarian Expansion Cohort: Subjects with recurrent disease or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma who have previously progressed while receiving or within 6 months of completing a platinum-containing regimen.
    • NSCLC Expansion Cohort: Histologic or cytologic diagnosis of NSCLC (squamous or non-squamous or NSCLC-not specified)
    • Dose Escalation, Renal insufficiency, NSCLC and CPI-Treated Expansion Cohorts: For subjects with urothelial cancer and NSCLC: Subjects must submit a tumor tissue for Nectin-4 expression. Enrollment for these subjects is not dependent on the immunohistochemistry using the H-Score (IHC H-Score).
    • Ovarian Expansion Cohort: Subjects must have tumor tissue positive (IHC H-score ≥150) for Nectin-4 expression
    • For Dose Escalation, NSCLC and Ovarian Expansion Cohorts: Subject must have failed at least one prior chemotherapy regimen for metastatic disease (urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy)
    • For the CPI-Treated Expansion Cohort: Subject must have received prior treatment with a CPI in the metastatic setting.
    • Subjects must have measurable disease according to RECIST (version 1.1)
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Life expectancy of ≥ 3 months
    • Negative pregnancy test (women of childbearing potential)
    • Hematologic function, as follows (no red blood cell or platelet transfusions are allowed within 14 days of the first dose of enfortumab vedotin):
      • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
      • Platelet count ≥ 100 x 10^9/L
      • Hemoglobin ≥ 9 g/dL
    • Renal function, as follows: Dose Escalation, NSCLC, Ovarian, and CPI Treated Expansion Cohorts: creatinine clearance of ≥ 30 mL/min by the Cockcroft-Gault equation or as measured by 24 hour urine collection. For the Renal Insufficiency Expansion Cohort: creatinine clearance estimate ≥15 ml/min and <30 ml/min by Cockcroft-Gault equation or as measured by 24 hour urine collection.
    • Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
    • Serum albumin ≥2.5 g/dL
    • Aspartate aminotransferase (AST) ≤ 1.5 x ULN
    • Alanine aminotransferase (ALT) ≤ 1.5 x ULN
    • International normal ratio (INR) < 1.3 or ≤ institutional ULN (or ≤ 3.0 if on therapeutic anticoagulation)
    • Sexually active fertile subjects, and their partners, must agree to use medically accepted double-barrier methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and at least 6 months after termination of study therapy
    • Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form
    MaximizeExclusion Criteria
    • Preexisting sensory neuropathy Grade ≥ 2
    • Preexisting motor neuropathy Grade ≥ 2
    • Uncontrolled central nervous system metastases
    • Use of any investigational drug within 14 days prior to the first dose of study drug
    • Any anticancer therapy within 14 days prior to the first dose of study drug, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy or any other agents to treat cancer (anti-hormonal therapy given as adjuvant therapy for early-stage estrogen receptor (ER) positive breast cancer is not considered cancer therapy for the purpose of this protocol)
    • Subjects with immunotherapy related adverse events requiring high doses of steroids (≥ 40 mg/day of prednisone) are not eligible.
    • Any P-glycoprotein (P-gp) inducers/inhibitors or strong cytochrome P4503A (CYP3A) inhibitors within 14 days prior to the first dose of study drug
    • Thromboembolic events and/or bleeding disorders ≤ 14 days (e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE)) prior to the first dose of study drug
    • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of enfortumab vedotin.
    • Known Human Immunodeficiency Virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS)
    • Subjects with a positive Hepatitis B surface antigen and/or antihepatitis B core antibody. Subjects with a negative polymerase chain reaction (PCR) assay are permitted with appropriate antiviral prophylaxis.
    • Active Hepatitis C infection. Subjects who have been treated for Hepatitis C infection can be included if they have documented sustained virologic response of ≥ 12 weeks.
    • Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
    • Known sensitivity to any of the ingredients of the investigational product enfortumab vedotin (ASG-22CE)
    • Major surgery within 28 days prior to first dose of study drug
    • History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Subjects with nonmelanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low risk localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any time (if complete resection was performed) are allowed.
    • History of uncontrolled diabetes mellitus or diabetic neuropathy within 3 months of the first dose of study drug. Uncontrolled diabetes is defined as hemoglobin A1C (HbA1c) ≥ 8% or HbA1c > 7 to < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
    • Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
    • Condition or situation which may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
    • Any medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures
    • Has ocular conditions such as:
      • Active infection or corneal ulcer (e.g. keratitis)
      • Monocularity
      • History of corneal transplantation
      • Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration)
      • Uncontrolled glaucoma (topical medications allowed)
      • Uncontrolled or evolving retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disorder

    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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