Trial | NCT01858181  Report issue

Title

Phase I Study of Subcutaneous Ocaratuzumab in Patients With Previously Treated CD20+ B-Cell Malignancies
A Phase I Study of Subcutaneous Ocaratuzumab (Fab- and Fc-engineered Anti-CD20 Monoclonal Antibody) in Patients With Previously Treated CD20+ B-Cell Malignancies

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    9
Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity (ADCC) effector function.

A previous phase I/II study of intravenously (IV) administered ocaratuzumab in refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and well-tolerated at doses up to 375mg/ m2 weekly for four weeks.

In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4 doses, 80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety, tolerability, pharmacokinetic, and pharmacodynamic analyses.
Study Started
Jan 31
2015
Primary Completion
Dec 31
2015
Anticipated
Last Update
Mar 03
2014
Estimate

Biological ocaratuzumab

  • Other names: AME-133v, LY2469298

Cohort 1 Experimental

SC ocaratuzumab 40 mg weekly x 4 doses

Cohort 2 Experimental

SC ocaratuzumab 80 mg weekly x 4 doses

Cohort 3 Experimental

SC ocaratuzumab 80 mg weekly x 8 doses

Criteria 

Inclusion Criteria:

Age >18 years;
Histologically confirmed diagnosis of a CD20+ B-cell malignancy;
Received at least one prior treatment regimen;historically documented CD20-positivity is acceptable;
Appropriate for single agent study drug therapy as prescribed by this protocol;
ECOG performance status 0 to 2;

Adequate hematopoietic, renal, and hepatic functions defined as:

Absolute neutrophil count greater than 1000 /mm³
Platelet count greater than 75,000/mm³
Hemoglobin greater than 8.5 g/dL
Serum creatinine ≤ 1.5x upper limit of normal
AST, ALT, and total bilirubin ≤ 3x upper limit of normal;
Ability to understand and the willingness to sign a written informed consent document;
Life expectancy of 6 months or greater.

Exclusion Criteria:

Anti-CD20 therapy within 4 weeks of enrollment;
Systemic chemotherapy or immunotherapy within 14 days of enrollment;
Chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or greater;
Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study;
Active infection, chronic or severe infection requiring ongoing antimicrobial therapy.
Positivity for hepatitis B (defined as HepBs Antigen +), hepatitis C (defined as HepC Antibody +), or HIV; HIV positive patients on antiretroviral therapy will be excluded;
History of allergic reactions attributed to compounds of similar chemical or biologic composition;
Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication;
Women who are pregnant or breast-feeding;
Women of child bearing potential who are unwilling to use effective contraception for the duration of the study drug administration and 6 months after final dose of drug is administered;
Psychiatric illness/social situations that would limit compliance with study requirements;
Participation in other investigational studies while enrolled on this trial.
No Results Posted