A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer

Summary

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.

Key Facts

Interventions

Conditions

Eligibility

Inclusion Criteria:

* Subjects with recurrent disease or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
* Subjects must have received at least one prior platinum containing regimen and one of the following: persistent disease (either stable disease, partial response or nonmeasureable disease after first line therapy) or progressive disease at anytime

Exclusion Criteria:

* No epithelial ovarian tumors of low malignant potential
* Active infection requiring treatment with systemic anti-infectives within 72 hours of screening
* Use of any investigational drug within 30 days prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
* Prior monoclonal antibody therapy

Outcome Measures

Locations

Linked Diseases