A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
Urinary Bladder NeoplasmsNon-muscle Invasive Bladder Cancer (NMIBC)
Investigational drug(s) / intervention(s)
Alpha1HTransurethral Resection of Bladder Tumor (TURBT)Intravesical Chemotherapy
Alpha1H: Administered via intravesical instillation directly into the urinary bladder. Participants in the experimental group receive a total of 6 instillations on Days 1, 3, 5, 8, 15, and 22 over approximately 1 month prior to TURBT. During each treatment, participants are asked to retain the solution in the bladder for up to 2 hours.
Transurethral Resection of Bladder Tumor (TURBT): Standard endoscopic surgical procedure performed through the urethra to resect and remove papillary bladder tumor tissue. Performed approximately 30 days after study entry (on Visit 8). Resected tumor tissue is collected for histopathology and central analysis.
Intravesical Chemotherapy: A single early intravesical instillation of standard-of-care chemotherapy (epirubicin, mitomycin, or gemcitabine) administered into the urinary bladder shortly following TURBT surgery in accordance with local institutional guidelines.
Study summary
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H.
The main questions it aims to answer are:
* Does giving drug Alpha1H before surgery lower the risk of cancer returning or worsening compared to standard care alone?
* Is drug Alpha1H safe and well-tolerated by participants? Researchers will compare participants receiving drug Alpha1H before standard surgery to participants receiving standard care alone to see if drug Alpha1H lowers the risk of cancer returning or progressing.
Participants will:
* Be randomly assigned to receive either drug Alpha1H before surgery or standard care alone.
* Receive drug Alpha1H directly into the bladder 6 times over about 1 month if assigned to the Alpha1H group.
* Hold the liquid in the bladder for up to 2 hours during each visit.
* Undergo standard surgery through the urethra (TURBT) to remove remaining tumor tissue.
* Visit the clinic regularly for follow-up checkups (including bladder examinations and urine tests) to check if the cancer returns.
* Fill out questionnaires about their quality of life.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Signed and dated informed consent.
* Low- or intermediate-risk non-muscle-invasive bladder cancer (NMIBC) meeting one of the following definitions:
* Low-risk NMIBC: Primary, solitary, Ta, low-grade, 0.5 cm to 3 cm.
* Intermediate-risk NMIBC (low-to-intermediate risk subgroup per IBCG classification):
* Primary multifocal (\<10 lesions), Ta, low-grade, 0.5 cm to 3 cm;
* Recurrent solitary, Ta, low-grade, 0.5 cm to 3 cm; or
* Recurrent multifocal (\<10 lesions), Ta, low-grade, \>1 year after previous recurrence.
* Men and women aged 18 years or older.
* Negative pregnancy test at screening for women of childbearing potential.
* Women of childbearing potential must agree to use highly effective contraception methods throughout study participation; men of childbearing potential must refrain from donating sperm during the study.
* Ability to retain bladder contents for 2 hours.
Exclusion Criteria:
* Patient with non-papillary tumor appearance at the time of initial cystoscopy.
* Previous history of T1 or high-grade disease in recurrent tumors.
* Patients with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
* Previous intravesical BCG immunotherapy.
* Patients with any other cancer diagnosis within the last 5 years (except for skin basalioma).
* Acute urinary tract infection requiring antibiotic treatment.
* Prior radiotherapy or systemic chemotherapy.
* WHO performance status of 3 or 4.
* Any other investigational agent or non-marketed product within one month prior to Visit 1 and during the trial.
* Known active HIV infection, defined as detectable HIV viral load at screening.
* Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA at screening.
* Active hepatitis C virus (HCV) infection, defined as anti-HCV antibody positivity with detectable HCV RNA at screening in a patient not on stable antiviral treatment.
* Any concurrent illness that may render a participant ineligible or limit compliance with study requirements.
* Previously enrolled in this trial.
Primary outcome measure(s)
Event-Free Survival (EFS) — From randomization until the occurrence of an EFS event or study completion, assessed at 3, 6, 9 (optional), and 12 months post-randomization, and every 6 months thereafter for up to 3 years.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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