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XmAb2513

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00606645Safety Study of XmAb®2513 to Treat Hodgkin Lymphoma or Anaplastic Large Cell LymphomaPHASE1 COMPLETED 23Dec 1, 2007Apr 1, 2010Apr 21, 20144 United States
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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 — 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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