drugset
drugset / Trial / NCT00606645

Safety Study of XmAb®2513 to Treat Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma

NCT00606645 ↗

Phase 1 Completed 23 enrolled Xencor, Inc.
NaSingle-groupOpen-labelTreatment

Summary

An open-label, multi-dose, single-arm, Phase 1 dose escalation study of XmAb®2513 was conducted to define the MTD or recommended dose(s) for further study, to determine safety and tolerability, to characterize PK and immunogenicity, and to evaluate antitumor activity of XmAb2513 in patients with HL and ALCL (non-cutaneous) and who have received two or more prior therapeutic regimens. There will be no intra-patient dose escalation.

Timeline

Start
2007-12
Primary completion
2010-04
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject XmAb2513 Unknown 0.3 mg/kg Intravenous
Subject XmAb2513 Unknown 1 mg/kg Intravenous
Subject XmAb2513 Unknown 3 mg/kg Intravenous
Subject XmAb2513 Unknown 6 mg/kg Intravenous
Subject XmAb2513 Unknown 9 mg/kg Intravenous
Subject XmAb2513 Unknown 12 mg/kg Intravenous

Indications

Hodgkins lymphoma anaplastic large cell lymphoma