Phase 1 Bladder Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with bladder cancer through laboratory testing, specifically high-risk non-muscle-invasive bladder cancer (cancer that has not spread into the bladder muscle) with certain features such as high-grade tumors, cancer in the lining only (carcinoma in situ), tumors at stage T1, tumors larger than 3 cm, multiple tumors, or returning tumors — this applies to the first phase of the trial. Later phases also include people whose cancer came back or persisted after a specific type of bladder treatment called BCG therapy, as well as people with muscle-invasive bladder cancer at certain stages (confirm with trial site for which group applies).
• People who are either not medically suitable for bladder removal surgery (as determined by a urologist) or who have chosen not to have that surgery — this applies to all groups except those with muscle-invasive bladder cancer in Phase Ib Cohort B.
• People aged between 18 and 75 years old (inclusive).
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People whose doctors estimate they have a life expectancy of at least 2 years.
• People whose blood, liver, kidney, and clotting test results fall within the ranges required by the trial (the trial team will check these through blood tests).
• Women who are before menopause must have a negative blood pregnancy test at the screening stage, and must agree to use reliable contraception (such as barrier methods or abstinence) during the trial and for at least 6 months after the last dose.
• People who have read the trial information, understood it, and have voluntarily signed a written consent form before joining.

Who may not be able to join:

• People whose cancer has spread to other parts of the body, or who have cancer in multiple nearby lymph nodes or certain pelvic lymph nodes, or who have a blocked kidney (hydronephrosis).
• People who have had radiation therapy to the pelvic area within the past 5 years.
• People who have previously received treatments based on a type of virus called adenovirus, such as certain cancer-fighting virus therapies or the CanSino COVID-19 vaccine.
• People who currently have a urinary tract infection or bacterial bladder infection (though people may be reconsidered once the infection has been successfully treated).
• People with significantly elevated liver or kidney test results that cannot be explained.
• Women who are pregnant, breastfeeding, or unwilling to use contraception at any point during the study; and men who are unwilling to use effective contraception.
• People who have had a different type of cancer in the past 5 years that the trial doctor believes could interfere with the study or that still requires ongoing systemic treatment.
• People who are unable to hold a liquid in their bladder for 1 hour or who cannot tolerate bladder surgery.
• People who have recently received other cancer treatments (such as chemotherapy, radiotherapy, immunotherapy, or certain targeted drugs) within specified timeframes before starting the trial — the exact timeframes vary depending on the treatment type (confirm with trial site).
• People with a history of serious heart or blood vessel conditions, including dangerous heart rhythm problems, certain electrical conduction issues in the heart, recent heart attack or stroke (within 6 months), significant heart failure, uncontrolled high blood pressure, or certain structural heart problems.
• People with autoimmune diseases, immune system disorders, or who have had an organ transplant.
• People with an active infection currently requiring treatment, or who have an unexplained fever above 38.5°C at the time of screening.
• People who test positive for HIV or syphilis antibodies; people with active hepatitis B or active hepatitis C (certain people with hepatitis B or C who meet specific conditions may still be eligible — confirm with trial site).
• People with uncontrolled seizures, nervous system disorders, or serious mental health conditions affecting thinking and awareness.
• People who still have significant side effects from previous cancer treatments that have not improved to a mild level (with some exceptions such as hair loss, as determined by the trial doctor).
• People who are currently taking antiviral medications or who have taken antiviral medications within 2 weeks before starting the trial drug.
• People who have received a live virus vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, or typhoid vaccines) within 4 weeks before starting the trial drug. Most injected flu vaccines are permitted, but nasal spray flu vaccines are not.
• People who have taken steroid medications above a certain dose (such as prednisone above 10 mg) or other immune-suppressing medications within 14 days before starting the trial, with some exceptions such as skin creams, eye drops, joint injections, or short-term preventive use (confirm with trial site).
• People with a history of severe allergies or a generally allergic constitution.
• People who have had a bone marrow or organ transplant from another person.
• People whom the trial doctor considers unsuitable for any other reason.

Important: Always verify eligibility with the trial site directly before applying.