NCT05982834

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

Disitamab Vedotin Combined With Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive Metastatic Gastric Cancer: A Prospective Phase Ib/II Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-positive Gastric Cancer
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin combined with fruquintinib and Tislelizumab	Disitamab Vedotin 2.5mg/m2 ivgtt d1,15, fruquintinib 4mg qd po d1-21 and Tislelizumab 300mg ivgtt,q4w

Timeline

• Start date: 2023-05-09
• Primary completion: 2025-05-01
• Completion: 2025-12-01
• First posted: 2023-08-09
• Last updated: 2023-08-09

Locations

1 site across 1 country: China