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: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamlet Pharma AB

Criteria

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.