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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

31. August 2026 aktualisiert von: Hamlet Pharma AB

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

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

194

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Tschechien
      • Prague, Tschechien, 15000
        • Fakultní nemocnice Motol a Homolka

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Alpha1H
Participants receive 6 intravesical instillations of Alpha1H over approximately 1 month prior to transurethral resection of bladder tumor (TURBT).
Arzneimittel: 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.
Verfahren: 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.
Arzneimittel: 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.
Aktiver Komparator: Standard of Care
Participants receive standard of care consisting of transurethral resection of bladder tumor (TURBT) followed by a single early intravesical instillation of standard chemotherapy.
Verfahren: 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.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Event-Free Survival (EFS)
Zeitfenster: 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.
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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Complete Response (CR) Rate
Zeitfenster: Day 30 (±5 days), prior to TURBT
Day 30 (±5 days), prior to TURBT
Overall Survival (OS)
Zeitfenster: From randomization through study completion (assessed at 3, 6, 9 [optional], and 12 months, and every 6 months thereafter for up to 3 years).
From randomization through study completion (assessed at 3, 6, 9 [optional], and 12 months, and every 6 months thereafter for up to 3 years).
Tumor Response (Morphological and Cellular)
Zeitfenster: Baseline (Day 1) to Day 30 (±5 days)
Assessed as: (1) change in papillary tumor size (% reduction from baseline); (2) tumor cell shedding in urine (cells/mL); (3) apoptosis in shed cells (% TUNEL-positive cells); (4) Alpha1H uptake in shed cells (% Alpha1H-positive cells). Each parameter reported separately.
Baseline (Day 1) to Day 30 (±5 days)
Tumor Gene Expression
Zeitfenster: Baseline (Day 1) to Day 30 (±5 days)
Assessed by RNA sequencing (whole transcriptome) in tumor tissue and urine RNA. Reported as number of differentially expressed cancer-related genes and pathways between the Alpha1H and SOC arms.
Baseline (Day 1) to Day 30 (±5 days)
Urinary Biomarkers and Immune Response
Zeitfenster: Day 1, 3, 5, 8, 15, and 22 (pre- and post-instillation), and Day 30 (±5 days)
Assessed by proteomic profiling of urine samples. Reported as change in concentration (pg/mL) of cytokines, chemokines, and interferons between pre- and post-instillation samples, compared between the Alpha1H and SOC arms.
Day 1, 3, 5, 8, 15, and 22 (pre- and post-instillation), and Day 30 (±5 days)
Incidence and Severity of Adverse Events (AEs)
Zeitfenster: From Visit 1 (Screening) through Visit 9 (Day 40/50) and follow-up period (up to 3 years)
From Visit 1 (Screening) through Visit 9 (Day 40/50) and follow-up period (up to 3 years)
Change in Quality of Life (QoL) as Assessed by the QLQ-NMIBC24 Questionnaire
Zeitfenster: From Visit 1 (Screening) through follow-up visits (up to 3 years)
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Muscle-Invasive Bladder Cancer Module (EORTC QLQ-NMIBC24), a 24-item, disease-specific patient-reported outcome instrument. Each domain score is linearly transformed to range from 0 to 100. On functional scales (e.g., sexual function), higher scores indicate better functioning; on symptom-related scales (e.g., urinary symptoms, future perspective), higher scores indicate greater symptom burden. Scores are calculated per the EORTC scoring manual.
From Visit 1 (Screening) through follow-up visits (up to 3 years)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hamlet Pharma AB

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Juli 2029

Studienabschluss (Geschätzt)

1. Juli 2029

Studienanmeldedaten

Zuerst eingereicht

26. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. August 2026

Zuerst gepostet (Tatsächlich)

4. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HP003-001
  • 2026-525531-16-00 (Ctis)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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