NCT07804056RecruitingPhase 3
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
A Randomized Phase III 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
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 194 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- 17 Sept 2026
- Primary completion date
- Jul 2029
- Lead sponsor
- Hamlet Pharma AB
- Diseases
- Bladder cancer
- NCT number
- NCT07804056
- EU CT number
- 2026-525531-16-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 194
- From 17 Sept 2026 to the primary completion date, Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of T1 or high-grade disease in recurrent tumors.
- Previous intravesical BCG immunotherapy.
- Prior radiotherapy or systemic chemotherapy.
- Any other investigational agent or non-marketed product within one month prior to Visit 1 and during the trial.
- Any concurrent illness that may render a participant ineligible or limit compliance with study requirements.
- Previously enrolled in this trial.
Other illness
- Patients with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC).
- Patients with any other cancer diagnosis within the last 5 years (except for skin basalioma).
- Acute urinary tract infection requiring antibiotic treatment.
- 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.
Other
- Patient with non-papillary tumor appearance at the time of initial cystoscopy.
- WHO performance status of 3 or 4.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni Nemocnice Motol a Homolka Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.