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

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.

Timeline

Start

2018-05-21

Primary completion

2021-12

Completion

2023-12

Outcome

Met primary endpoint

paper all primary end points of safety and efficacy of alpha1-oleate treatment are reached, as evaluated in an interim analysis. PMID 34103518 ↗

Publications

• Haq F, Chinchankar S, Ambite I, Ahmadi S, Tran H, Nazari A, Brisuda A, Hacek J, Babjuk M, Svanborg C. Identification of alpha1-oleate as a potent regulator of adipokine-dependent metabolism, in bladder cancer tissue. Cancer Metab. 2026 Jun 23;14(1):21. doi: 10.1186/s40170-026-00445-2.
• Brisuda A, Ho JCS, Kandiyal PS, Ng JT, Ambite I, Butler DSC, Hacek J, Wan MLY, Tran TH, Nadeem A, Tran TH, Hastings A, Storm P, Fortunati DL, Esmaeili P, Novotna H, Hornak J, Mu YG, Mok KH, Babjuk M, Svanborg C. Bladder cancer therapy using a conformationally fluid tumoricidal peptide complex. Nat Commun. 2021 Jun 8;12(1):3427. doi: 10.1038/s41467-021-23748-y.

Drugs

Indications