Trials / Completed
CompletedNCT00606645
Safety Study of XmAb®2513 to Treat Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Xencor, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | XmAb2513 | Intravenous infusion of XmAb2513 administered at a dose of 0.3, 1.0, 3.0, 6.0, 9.0, or 12 mg/kg in sequential dose cohorts. |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2010-04-01
- Completion
- 2010-04-01
- First posted
- 2008-02-04
- Last updated
- 2014-04-21
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00606645. Inclusion in this directory is not an endorsement.