Status:
Recruiting
Clinicaltrials.gov identifier:
Sponsor:
Aadi, LLC
Participating centers:
New York and Nashville
Accrual:
estimated 40
Study Design:
A Phase 1/2, Single Arm Open-Label Study to Determine the Efficacy and the Safety of Albumin-bound rapamycin nanoparticles (ABI-009) in recurrent or BCG-refractory NMIBC patients.
Rationale:
Rapamycin is an MTOR inhibitor that has demonstrated activity against bladder cancer in preclinical models. Intravesical administration, however, is not practical for most targeted therapies. Nanoparticles may allow for increased delivery of therapeutic agents across the urothelium and has been demonstrated to be active with agents such as paclitaxel. Therefore, now rapamycin is being evaluated in this trial.
Comments:
Nanotechnology allows delivery of a variety of therapeutics intravesically and has been successfully done with paclitaxel. Therefore, this trial has a lot of potential.
