NCT06123468

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophagogastric Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Sacituzumab govitecan	10 mg/kg i.v. at day 1 and day 8 of each 21-day cycle (Q3W) for max 17 cycles (max. 12 months treatment)

Timeline

• Start date: 2024-04-17
• Primary completion: 2026-01-07
• Completion: 2026-01-07
• First posted: 2023-11-08
• Last updated: 2026-01-08

Locations

8 sites across 2 countries: Austria, Germany