This is the first in human study of AGS-8M4 given every 2 weeks to subjects with advanced ovarian cancer. AGS-8M4 will be administered as an IV infusion until the disease worsens.
All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled sequentially into 1 of the 4 planned dose cohorts according to a standard dose escalation study design. A disease assessment will be performed at study week 9 (+/- 3 days). The assessment will be based on clinical signs and symptoms, changes in radiographic images, and changes in CA-125 levels. Subjects without evidence of disease progression may continue to receive AGS-8M4 during the extended treatment period at the dose and schedule of their assigned cohort until disease progression intolerability of AGS-8M4 or consent withdrawal. For subjects that continue dosing, disease assessments will be performed every 8 weeks during the extended treatment period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-8M4.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
IV Infusion
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
New York, New York, United States
Unnamed facility
New York, New York, United States
Incidence of adverse events
Time frame: Throughout the treatment
Assessment of PK variables
Time frame: Weeks 1-3, week 5, week 7 week 11, every 2 weeks during extension period, 2 and 3 months after last dose
Incidence of anti-AGS-8M4 antibody formation
Time frame: Week 1, week 7, week 11, week 15 (extension only), 2 and 3 months after last dose
Changes in tumor status per RECIST
Time frame: Week 9, and every 8 weeks during the extended treatment period
Changes in CA-125 levels
Time frame: Week 9, and every 8 weeks during the extended treatment period
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