Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: 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.
  Half of the subjects will receive treatment with alpha1H and the other half will receive placebo. The treatment is given on 6 occasions during a period of 22 days. The total study duration is 8 - 12 weeks including follow-up.

Detailed description: Protein-lipid complexes represent a new type of tumouricidal biologicals, with broad effects against cancers of different origins. The investigational product alpha1H is a synthetic peptide, corresponding to the alpha1 domain of α-lactalbumin, in complex with oleic acid. Alpha1H is a further development product of HAMLET, a complex between human alpha-lactalbumin and oleic acid, which has shown broad anti-tumor activity with a high degree of selectivity.
  This study is a combined phase 1/2, placebo controlled, double blind study in subjects with non-muscle invasive bladder cancer awaiting transurethral resection of bladder (TURB). The study is randomized 1/1 and the subjects will receive intravesical instillation of either alpha1H or placebo on 6 occasions during a period of 22 days (on days 1, 3, 5, 8, 15 and 22).
  Cell shedding is quantified and characterized at each treatment occasion. The bladder tumors are characterized prior treatment and prior to the scheduled surgery. Remaining tumors will be removed by TURB (according to European Association of Urology (EAU) Guidelines recommendations) and tissues will be obtained for analyses.
  A follow-up Visit will take place 30 days after the last administration of study treatment.
  The total study duration is 8 - 12 weeks.

Eligibility: 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.

Relevance to patient case: not relevant