Phase 1b Study Of Andecaliximab (Gs-5745, Adx) As Monotherapy And In Combination With Nivolumab (Nivo) In Japanese Subjects With Gastric Or Gej Adenocarcinoma.

137Background: Matrix metalloproteinase 9 (MMP9) is a poor prognostic factor in gastric cancer. Preclinical studies suggest that MMP9 inhibition can relieve immune suppression, promote T cell infiltration, and potentiate benefits of checkpoint blockade. ADX is a monoclonal antibody that inhibits the enzymatic activity of MMP9. In this study, safety, PK, exploratory biomarkers, and preliminary efficacy of ADX alone and in combination with nivo were assessed. Methods: Up to 6 Japanese subjects were to be enrolled in Cohort 1 (monotherapy ADX 800 mg IV Q2W), followed by 10 subjects in Cohort 4 (nivo plus ADX). Treatment was continued until PD or unacceptable toxicity. Tumor biopsies were collected before treatment and at week 6. Results: As of August 2018, 8 and 10 subjects were dosed in Cohort 1 u0026 4, respectively. All subjects received prior chemotherapy (median: 2, range: 1-4). In Cohort 1, Grade 3 AEs included anemia (25%), fatigue, general physical health deterioration, anorexia, and hydronephrosis (each...