Clinical Trial: Safety Study of XmAb®2513 to Treat Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1 Study of Every Other Week XmAb®2513 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma<
Brief 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.
Detailed Summary:
Sponsor: Xencor, Inc.
Current Primary Outcome: Identification of the maximum tolerated dose and identification of the recommended dose of XmAb®2513 for evaluation in future studies. [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability [ Time Frame: 1 year ]
- Assessment of immunogenicity [ Time Frame: 1 year ]
- Objective response rate, disease control rate, and progression free survival. [ Time Frame: 1 year ]
- Change in solCD30 [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Xencor, Inc.
Dates:
Date Received: January 21, 2008
Date Started: December 2007
Date Completion:
Last Updated: April 18, 2014
Last Verified: April 2014
