Spots Global Cancer Trial Database for Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma

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Trial Identification

Brief Title: Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma

Official Title: A Phase Ib/II Single-arm, Multicenter Study of Sacituzumab-govitecan, a TROP-2 Targeting Antibody Linked With SN38, for Patients With Metastatic Esophagogastric Adenocarcinoma

Study ID: NCT06123468

Conditions

Esophagogastric Adenocarcinoma

Interventions

Sacituzumab govitecan

Study Description

Brief Summary: The study is a open-label, single-arm, multicenter, phase Ib/II trial assessing the efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma

Detailed Description: All eligible enrolled patients will receive:Sacituzumab-govitecan 10 mg/kg i.v. at day 1 and day 8 of each 21-day cycle (Q3W). Patients will receive the treatment for a maximum of 12 months or until disease progression, unacceptable toxicity or withdrawal of consent, whichever occurs first.The primary objective of the trial is to evaluate the efficacy (primary endpoint: Overall Response Rate ORR, complete response + partial response) of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma. The secondary objectives are to further characterize the efficacy of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma and to evaluate safety and tolerability of sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma. Secondary endpoints comprise the assessment of Clinical benefit rate (CBR, complete response + partial response + stable disease), Progression-free survival (PFS), Overall survival (OS), ORR, CBR, PFS and OS in the subgroup of TROP-2 overexpression, toxiticy. In addition, tissue and blood samples will be analyzed to evaluate the TROP-2 expression during treatment with sacituzumab-govitecan for metastatic esophagogastric adenocarcinoma. 56 patients will be enrolled in this trial.