Clinical trial · Interventional
A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer
A Randomized Placebo Controlled Phase I/II Study Evaluating the Safety and Efficacy of alpha1H in Adult Patients With Non-muscle Invasive Bladder Cancer Awaiting Transurethral Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alpha1H, 37 mg/mL | Drug | — | UNRESOLVED |
| alpha1H, 7.4 mg/mL | Drug | — | UNRESOLVED |
| alpha1H, 74 mg/mL | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- alpha1H, 7.4 mg/mL
- description
- alpha1H (7.4 mg/mL), solution for instillation, 30 mL
- interventionNames
- Drug: alpha1H, 7.4 mg/mL
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Placebo, 0.9% NaCl (sodium chloride), 30 mL
- interventionNames
- Other: placebo
- type
- EXPERIMENTAL
- label
- alpha1H, 37 mg/mL
- description
- alpha1H (37 mg/mL), solution for instillation, 30 mL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDHaq 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. PMID 42337683
- DERIVEDAhmadi S, Ambite I, Brisuda A, Hacek J, Haq F, Sabari S, Vanarsa K, Mohan C, Babjuk M, Svanborg C. Similar immune responses to alpha1-oleate and Bacillus Calmette-Guerin treatment in patients with bladder cancer. Cancer Med. 2024 Apr;13(7):e7091. doi: 10.1002/cam4.7091. PMID 38553868
- DERIVEDBrisuda 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. PMID 34103518