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Antibody-Drug Conjugate
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
Guangzhou, China
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
No Placebo-Only Group
Pivotal Trial
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.
See full description
Eligible Conditions
- Stomach Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within approximately 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival (OS)
Secondary study objectives
Disease control rate (DCR)
Duration of relief (DOR)
Objective remission rate (ORR)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
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Who is running the clinical trial?
RemeGen Co., Ltd.Lead Sponsor
82 Previous Clinical Trials
10,636 Total Patients Enrolled