This is a dose escalation study in female subjects with relapsed ovarian cancer (including epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer). Approximately 30 to 40 subjects will be administered a combination of conatumumab and birinapant. In the initial dose-escalation stage of the study, adult female subjects will receive conatumumab in combination with increasing doses of birinapant in dose-escalation cohorts to determine the MTD of birinapant when administered with a fixed dose of conatumumab. In safety expansion stage, adult female subjects will receive conatumumab in combination with birinapant at the MTD of the combination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Dose Escalation: Dose Level (1) - 13 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (2) - 13 mg/m2 (twice weekly for 4 weeks );
10 mg/kg IV on Day 1 and 15 of each cycle
TetraLogic research site
Fresno, California, United States
TetraLogic Research Site
San Luis Obispo, California, United States
TetraLogic Research Site
Fairway, Kansas, United States
TetraLogic Research Site
Boston, Massachusetts, United States
TetraLogic Research Site
Durham, North Carolina, United States
TetraLogic Research Site
Philadelphia, Pennsylvania, United States
TetraLogic Research Site
Philadelphia, Pennsylvania, United States
TetraLogic Research Site
Nashville, Tennessee, United States
TetraLogic Research Facility
Dallas, Texas, United States
Determination of Maximum Tolerated Dose (MTD)
Time frame: 28 Days
Clinical response as measured by RECIST (v1.1) criteria, CA 125 (GCIG criteria) and progression-free survival (PFS).
Time frame: Up to 4 months
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