drugset / Trial / NCT01029873
QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-escalation study of ALT-801 combined with cisplatin. The purpose of this study is to evaluate the safety, determine the Maximum-Tolerated Dose (MTD), and characterize the pharmacokinetic profile of ALT-801 given with cisplatin in patients who are chemotherapy naïve and have metastatic melanoma that is considered surgically incurable. The anti-tumor responses of ALT-801 with cisplatin will also be assessed in this trial.
Timeline
- Start
- 2010-02
- Primary completion
- 2011-11
- Completion
- 2013-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALT-801 | Protein / enzyme biologic | 0.04 mg/kg | Intravenous |
| Subject | ALT-801 | Protein / enzyme biologic | 0.06 mg/kg | Intravenous |
| Subject | ALT-801 | Protein / enzyme biologic | 0.08 mg/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |