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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

StatusNot Yet Recruiting
PhasePhase 3
Started2026-09
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07804056
Lead Sponsor Hamlet Pharma AB
Conditions Urinary Bladder Neoplasms, Non-muscle Invasive Bladder Cancer (NMIBC)
Enrollment 194 participants
Start Date 2026-09
Primary Completion 2029-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-04