A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.