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

NCT05980481 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

RC48-ADC（2.5mg/kg）

2.5 mg/kg intravenous infusion every 2 weeks

DRUG

Trastuzumab

First load dose is 8.0mg , then 6.0 mg/kg intravenous infusion every 3 weeks

DRUG

Toripalimab

3.0 mg/kg intravenous infusion every 2 weeks

DRUG

Oxaliplatin（130mg/m2 ）

130mg/m2 intravenous infusion Q3W

DRUG

Capecitabine（1000mg/m2）

1000mg/m2 per os Q3W

DRUG

RC48-ADC（2.0mg/kg）

2.0 mg/kg intravenous infusion every 2 weeks

DRUG

Capecitabine（750mg/m2）

750mg/m2 per os Q3W

DRUG

Oxaliplatin（100mg/m2 ）

100mg/m2 intravenous infusion Q3W

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Na Su, PhD · RemeGen Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05980481 on ClinicalTrials.gov