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

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 o

Trial Details

NCT ID
NCT07804056
Phase
PHASE3
Sponsor
Hamlet Pharma AB
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Alpha1H
  • Transurethral Resection of Bladder Tumor (TURBT)
  • Intravesical Chemotherapy
Locations (sample)
  • Prague, Czechia|50.08804,14.42076

Key Eligibility 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):

For full eligibility, visit ClinicalTrials.gov.

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