SAGA-a phase Ib/II single-arm, multicenter study of sacituzumab govitecan for patients with metastatic esophagogastric adenocarcinoma.

ABSTRACT:

Background

Treatment of metastatic and locally advanced unresectable esophagogastric adenocarcinoma (EGA) after first-line therapy has limited efficacy. Sacituzumab govitecan (SG) is an antibody-drug conjugate (ADC) linking a TROP-2-directed antibody to the topoisomerase-I inhibitor SN-38. EGA has a high TROP-2 positivity rate and is sensitive to topoisomerase inhibition. Thus far, limited data on the efficacy and safety of SG in this patient population are available.

Aim

To evaluate the safety and efficacy of SG in patients with metastatic EGA who progressed under previous treatment. Objective response rate (ORR) is the primary endpoint.

Trial design

SAGA is a single-arm, non-randomized, open-label multicenter phase Ib/II study. Patients after prior treatment with a

SUBMITTER: Kobitzsch B 

PROVIDER: S-EPMC12836631 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature