Eisal INPUT-102 Study for Non-muscle Invasive Bladder Cancer (NMIBC)
Lay Title: A Study Using the Research Drug E7766 to Treat your Bladder Cancer
Technical Title: INPUT-102: Intravesical Phase 1/1b study of STING Agonist E7766 in NMIBC including Subjects Unresponsive to BCG Therapy
Disease Type: Patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC) that are did not respond to previous treatment with BCG.
Basic information: The purpose of this research study is to test the safety of study drug E7766. The study will also identify the highest dose of E7766 that can be given without unacceptable side effects. The study drug is given intravesically (into the bladder) through a urinary catheter. This is a first-in-human study, which means that you will be one of the first people to receive this drug.
Research Procedures (not a complete list):
At the beginning of the study, patients will come to the clinic weekly for 6 weeks to be treated with study drug. There will be two overnight visits during this period. One overnight visit will require 30 hours of safety monitoring after treatment, and the second overnight visit will require 24 hours of safety monitoring.
After this period, each cycle will consist of 3 weekly doses separated by a dosing break. The cycles will begin at 3, 6, 12, 18, and 24 months.
During study visits, you will undergo physical exams, cardiac tests, and blood and urine tests. You may also need to provide a fecal sample. You will also undergo cystoscopies (examination to see the inside of your urinary bladder) and bladder biopsies periodically.
Eligibility Criteria (not a complete list):
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Read more about this study (NCT04109092) on ClinicalTrials.gov.