UnknownPhase 1/2

A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer

Czechia52 participantsStarted 2018-05-21

Plain-language summary

This study evaluates the tolerability and preliminary anti-tumour effect of alpha1H in adults with non-muscle invasive bladder cancer, who are awaiting transurethral surgery. In the main, blinded part of the study, one group of subjects will receive treatment with alpha1H and the other half will receive placebo. In a second, dose-escalation part of the study, a third and fourth group of subjects will receive increased doses of alpha1H. The treatment is given on 6 occasions during a period of 22 days. The study duration is 8 - 12 weeks including scheduled follow-up and up to 27 months when an optional 24-months non-interventional follow-up period is included.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Patient with non-muscle invasive papillary bladder cancer (NMIBC) based on cystoscopy appearance, on the waiting list for TURB. * Negative pregnancy test in women of childbearing potential. * Appropriate methods of contraception in women of childbearing potential during study. * Patients should be able to keep the content of the bladder for at least one hour. Exclusion Criteria: * Patient with a previous history of muscle invasive bladder cancer. * Patient with a history of NMIBC with an interval shorter than 6 months after previous TURB. * Previous intravesical Bacillus Calmette-Guerin (BCG) immunotherapy in the last 12 months. * Previous intravesical chemotherapy in the last 12 months. * Participants with any other cancer diagnosis within the last 5 years (except of skin basaliomas). * Acute urinary tract infection * Participants with prior radiotherapy or systemic chemotherapy. * Participants receiving any other investigational agent or non-marketed product 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.

What they're measuring

Safety as Adverse Events Profile

Timeframe: From signing of informed consent (Day 1) and until 30 days after the last dose (Day 52).

Efficacy as Cell Shedding

Timeframe: Days 1 to 22

Change from baseline in characteristics of papillary tumors

Timeframe: Prior to treatment (Baseline) and on Day 30, in connection with scheduled surgery.

Trial details

NCT IDNCT03560479

SponsorHamlet Pharma AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12

Contact for this trial

Catharina Svanborg, Prof.

+4640122505 catharina.svanborg@med.lu.se

View on ClinicalTrials.gov More Non-muscle Invasive Bladder Cancer trials