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Monoclonal Antibodies

MRG002 for Gastric Cancer

Phase 1 & 2
Waitlist Available
Led By Crystal Denlinger, MD
Research Sponsored by Shanghai Miracogen Inc.
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 baseline to study completion (24 months)
Awards & highlights

Study Summary

This trial is testing a new drug, MRG002, to see if it is safe and effective in treating patients with HER2-positive cancer. The trial will also look at how the body processes the drug and if it causes any immunity problems.

Eligible Conditions
  • Gastric Cancer
  • Gastroesophageal Junction Cancer
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to study completion (24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to study completion (24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (AEs)
Maximum Tolerated Dose (MTD)
Objective Response Rate (ORR)
+1 more
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Immunogenicity
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Solid TumorsExperimental Treatment1 Intervention
Phase I Dose Escalation: MRG002 will be administrated by an IV infusion of escalating doses (starting dose of 2.2 mg/kg, followed by 2.6 mg/kg) on Day 1 of every 3 weeks (21-day cycle).
Group II: Locally Advanced or Metastatic Gastric/GEJ CancerExperimental Treatment1 Intervention
MRG002 will be administrated by an IV infusion on Day 1 of every 3 weeks (21-day cycle).

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Who is running the clinical trial?

Shanghai Miracogen Inc.Lead Sponsor
20 Previous Clinical Trials
2,349 Total Patients Enrolled
Crystal Denlinger, MDPrincipal InvestigatorFox Chase Cancer Center
2 Previous Clinical Trials
1,484 Total Patients Enrolled
~32 spots leftby Jun 2025
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