This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of
ALT-801 combined with gemcitabine for patients who have BCG failure (defined as
refractory, relapsing or intolerant), non-muscle invasive bladder cancer and refuse or
are not medically fit to undergo a radical cystectomy recommended by the participating
urologist as the standard next therapy per urologic guidelines. The purpose of this study
is to confirm the safety and tolerability of a well-tolerated dose level of ALT-801, to
determine the Recommended Dose level (RD) and characterize the immunogenicity of ALT-801
combined with gemcitabine in treated patients. The anti-tumor responses will also be
assessed.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01625260.
Bladder cancer is the fifth most common cancer in the United States with an estimated
71,000 new cases and approximately 14,000 deaths in 2009. Bladder cancer is also the
costliest to treat per patient of all cancers, with annual direct medical expenditures in
excess of $3.7 billion in the United States. This is largely because approximately 70% of
all new cases of bladder cancer present as non-muscle invasive bladder cancer (NMIBC),
which tends to recur, requiring repeated interventions and long-term follow-up.
Altor Bioscience Corp. has developed a tumor-targeted IL-2 fusion protein, ALT-801,
comprising human recombinant IL-2 genetically linked to a TCR domain capable of binding a
tumor associated human p53 peptide presented in the context of HLA-A2.
ALT-801 will be evaluated as to whether it can prevent disease progression and allow for
bladder preservation to maintain the quality of life for patients with BCG failure,
defined as refractory, relapsing or intolerant, non-muscle invasive bladder cancer who
refuse or are not medically fit to undergo a radical cystectomy recommended by the
participating urologist as the standard next therapy per urologic guidelines.
Lead OrganizationAltor BioScience
