A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
Summary
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.
Timeline
- Start
- 2012-03-30
- Primary completion
- 2018-03-08
- Completion
- 2018-03-08
Outcome
Outcome not reported
Stopped (Enrollment): “The study was terminated early due to low enrollment.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALT-801 | Protein / enzyme biologic | 0.06 mg/kg | Intravenous |
| Subject | ALT-801 | Protein / enzyme biologic | 0.08 mg/kg | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |