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

NCT04714190 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2023-12-21

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2024-12-01
Completion
2025-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04714190 on ClinicalTrials.gov