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Antibody-Drug Conjugate

RC48-ADC for Stomach Cancer

Phase 3
Recruiting
Research Sponsored by RemeGen Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within approximately 3 years
Awards & highlights

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.

Eligible Conditions
  • Stomach Cancer
  • Gastric Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and within approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Disease control rate (DCR)
Duration of relief (DOR)
Objective remission rate (ORR)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RC48-ADCExperimental Treatment1 Intervention
Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
Group II: Physician's ChoiceActive Control3 Interventions
Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RC48-ADC
2019
Completed Phase 2
~340

Find a Location

Who is running the clinical trial?

RemeGen Co., Ltd.Lead Sponsor
80 Previous Clinical Trials
10,612 Total Patients Enrolled
~16 spots leftby Dec 2024
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