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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

NCT07804056 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-09-04

No results posted yet for this 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.

Conditions

  • Urinary Bladder Neoplasms
  • Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

DRUG

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.

PROCEDURE

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.

DRUG

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.

Sponsors & Collaborators

  • Hamlet Pharma AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-07-31
Completion
2029-07-31
FDA Drug
Yes

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804056 on ClinicalTrials.gov