drugset / Trial / NCT05982834

Disitamab Vedotin, Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive MGC

NCT05982834

Phase 1/2 Unknown 43 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

At present, there is no anti-HER2 therapy recommended by guidelines for second-line treatment of advanced gastric cancer with HER2-positive or HER2-overexpression, and combined with anti-angiogenic drugs are mainly used. Disitamab Vedotin is an anti-HER2 ADC, and its cytotoxic drugs are also anti-microtubule formation as the main mechanism of drugs. Fruquintinib is an anti-vascular TKI drug. In addition, according to the results of KEYNOTE-811, patients with HER2-positive advanced gastric cancer benefit significantly from immunotherapy, so the investigators hope to explore the possibility of immunotherapy in second-line treatment of HER2-positive advanced gastric cancer. Therefore, the study plans to enroll HER2-positive patients who have failed first-line therapy and explore the efficacy of the regimen of Disitamab Vedotin combined with fruquintinib combined with Tislezumab in second-line therapy.

Timeline

Start
2023-05-09
Primary completion
2025-05
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Monoclonal antibody 2.5 mg/m2 Intravenous
Subject Fruquintinib Small molecule 4 mg Oral
Subject Tislelizumab Monoclonal antibody 300 mg Intravenous

Indications