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drugset / Trial / NCT05980481

A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer

NCT05980481 ↗

Phase 2/3 Active not recruiting 201 enrolled RemeGen Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (HER2)-expression or non-expression participants with locally advanced or metastatic gastric cancer.

Timeline

Start
2023-08-04
Primary completion
2025-07-10
Completion
2026-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 750 mg/m2 Oral
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Disitamab Vedotin Monoclonal antibody 2 mg/kg Intravenous
Subject Disitamab Vedotin Monoclonal antibody 2.5 mg/kg Intravenous
Subject Oxaliplatin Small molecule 100 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background Toripalimab Monoclonal antibody 3 mg/kg Intravenous

Indications

gastric cancer