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XmAb2513

Phase 1

Hodgkin Lymphoma | Monoclonal antibody | Oncology |Xencor, Inc.|Last Updated: Apr 21, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

XmAb2513 · 1 trial · 2 indications

Phase 1 1
NCT00606645Safety Study of XmAb®2513 to Treat Hodgkin Lymphoma or Anaplastic Large Cell LymphomaHodgkin Lymphoma
COMPLETED23 Analytics
PHASE1COMPLETED
Safety Study of XmAb®2513 to Treat Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma
Hodgkin LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Identification of the maximum tolerated dose and identification of the recommended dose of XmAb®2513 for evaluation in future studies.
1 year

Secondary Endpoints

Safety and tolerability
1 year
Assessment of immunogenicity
1 year
Objective response rate, disease control rate, and progression free survival.
1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALXmAb2513

Interventions

NameTypeDescription
XmAb2513BIOLOGICALIntravenous 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Diagnosed with HL or ALCL. * Patients must have received two or more prior therapeutic regimens, one of which should include hematopoietic cell transplant, either autologous or allogeneic transplant. * If a hematopoietic cell transplant was refused, or the patient was not elig...

Countries:United States
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Frequently asked questions about XmAb2513

What is XmAb2513 used for in Hodgkin Lymphoma?

XmAb2513 is an investigational monoclonal antibody being studied for the treatment of Hodgkin Lymphoma. It was evaluated in a Phase 1 clinical trial that also included patients with Anaplastic Large Cell Lymphoma. The drug is not approved and remains in clinical development.

Who makes XmAb2513?

XmAb2513 is being developed by Xencor, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol XNCR. Xencor is the sponsor of the clinical trial for this investigational monoclonal antibody.

What phase is XmAb2513 in?

XmAb2513 is in Phase 1 clinical development. A single Phase 1 trial has been completed, and the drug is not FDA approved. It remains an investigational agent under study for Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma.

What clinical trials is XmAb2513 in?

XmAb2513 has one completed clinical trial, registered as NCT00606645, titled 'Safety Study of XmAb®2513 to Treat Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma.' The Phase 1 study enrolled 23 participants in the United States and was not randomized or blinded.

Is XmAb2513 FDA approved?

XmAb2513 is not FDA approved. It is an investigational monoclonal antibody that has completed a Phase 1 clinical trial for Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma, but it has not received regulatory approval for any indication.