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

A Multicenter, Open Label，Single Arm，Phase II Study to Evaluate the Effect and Safety Fruquintinib Combined With RC48 in the Treatment of Previously Treated HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a phase II, single arm study with main purpose to evaluate the safety, tolerability and efficacy 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. All eligible patients received Fruquintinib (4mg orally, once daily for 3 wks on/1 wk off) combined with of RC48( 2.5mg/kg by intravenous infusion during 30-90 min every 2 weeks) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib + RC48	Fruquintinib (4mg orally, once daily for 3 wks on/1 wk off) combined with of RC48( 2.5mg/kg by intravenous infusion during 30-90 min every 2 weeks)

Timeline

• Start date: 2022-05-07
• Primary completion: 2023-05-07
• Completion: 2025-05-07
• First posted: 2022-02-16
• Last updated: 2022-02-16

Locations

1 site across 1 country: China