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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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.
Rush University Medical Center
Chicago, Illinois, United States
Ohio State University
Columbus, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Identification of the maximum tolerated dose and identification of the recommended dose of XmAb®2513 for evaluation in future studies.
Time frame: 1 year
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
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