A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer (NCT03560479) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety as Adverse Events Profile
Timeframe: From signing of informed consent (Day 1) and until 30 days after the last dose (Day 52).
2
Efficacy as Cell Shedding
Timeframe: Days 1 to 22
3
Change from baseline in characteristics of papillary tumors
Timeframe: Prior to treatment (Baseline) and on Day 30, in connection with scheduled surgery.