NCT04714190

A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression

Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Gastric Cancer With HER2-overexpression

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 351 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer.

Detailed description

This study is a phase III multi-center, randomized, open-label, parallel control study to evaluate the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of HER2-overexpression locally advanced or metastatic gastric cancer. The HER2-overexpression is defined as: the HER2 IHC 3+ or 2+, regardless of FISH status.

Conditions

• Gastric Cancer
• HER2 Overexpressing Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	RC48-ADC	2.5 mg/kg IV every 2 weeks
DRUG	Paclitaxel injection	Administered according to label, as one option for Physician's Choice (determined before randomization)
DRUG	Irinotecan Hydrochloride Injection	Administered according to label, as one option for Physician's Choice (determined before randomization)
DRUG	Apatinib Mesylate Tablets	Administered according to label, as one option for Physician's Choice (determined before randomization)

Timeline

• Start date: 2021-03-24
• Primary completion: 2024-12-01
• Completion: 2025-06-30
• First posted: 2021-01-19
• Last updated: 2023-12-21

Locations

52 sites across 1 country: China