drugset / Trial / NCT05241899

A Phase II Clinical Study of Fruquintinib Combined With RC48 in the Treatment of Previously Treated HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Cancer

NCT05241899

NaSingle-groupOpen-labelTreatment

Summary

Although Pembrolizumab plus trastuzumab and chemotherapy is the standard of care for first-line treatment of HER2-positive advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer,there is no established therapy in the second-line setting. RC48 showed promising activity with manageable safety in patients with HER2-overexpressing, advanced G/GEJ cancer who have previously received at least two lines of chemotherapy.Fruquintinib in combination with Paclitaxel demonstrated encouraging preliminary clinical antitumor activity in patients with advanced GC in ph1b/2 study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in combination with RC48 in the treatment of previously treated HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer.

Timeline

Start
2022-05-07
Primary completion
2023-05-07
Completion
2025-05-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Disitamab Vedotin Other / unclassified 2.5 mg/kg Intravenous
Subject Fruquintinib Small molecule 4 mg Oral

Indications