Five Prime doses first patient in phase 1B trial of FPA150
Five Prime Therapeutics announced that it initiated patient dosing in the Phase 1b dose expansion portion of the Phase 1a/1b clinical trial of FPA150, a first-in-class immuno-oncology antibody that targets B7-H4. The objective of the Phase 1b dose expansion is to evaluate the safety, tolerability, pharmacokinetics and potential preliminary clinical benefit of FPA150 monotherapy in patients with breast, ovarian and endometrial cancers that over-express B7-H4. A subgroup of patients in the Phase 1b portion will undergo pre- and on-treatment biopsies to assess the pharmacodynamic effects of FPA150 on the tumor and the tumor microenvironment, including changes in markers of tumor immune infiltrates and cytokine levels. Endpoints for the Phase 1b portion include objective response rate, duration of response and progression-free survival.